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Consumer Healthcare Products Association

Unclaimed
Industry
Health, Wellness & Fitness
Staff
40
HQ
1625 Eye St NW, Washington, DC
Phone
+1 202-429-9260
Website
chpa.org

Engagement overview

Consumer Healthcare Products Association has filed 224 public comments across 192 dockets at 9 federal agencies, most actively at the Food and Drug Administration.

224
Comments filed
192
Dockets engaged
9
Agencies
Jul 16, 2026
Last filing

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Dockets (192)

sorted by most recent filing
FDANonrulemakingFDA-2025-P-6262

Requests that FDA, under FDCA §505G(b) (OTC monograph administrative order process), amend OTC Monograph M013 to update Drug Facts labeling for all over-the-counter acetaminophen-containing products. In the alternative, Petitioner asks FDA to initiate such an order on its own

1 of your filingslast filed Jul 16, 202610 co-filers
FDANonrulemakingFDA-2026-N-0809

Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments.

1 of your filingslast filed Jun 5, 20262 co-filers
EPANonrulemakingEPA-HQ-OW-2022-0946

Drinking Water Contaminant Candidate List 6 (CCL 6)

1 of your filingslast filed Jun 2, 202611 co-filers
FDANonrulemakingFDA-2025-N-4731

Increasing Availability of Nonprescription Drugs; Request for Information

2 of your filingslast filed May 21, 202616 co-filers
FDANonrulemakingFDA-2025-D-6131

General Considerations for the Use of New Approach Methodologies; Draft Guidance for Industry; Availability

1 of your filingslast filed May 20, 20261 co-filers
FDANonrulemakingFDA-2026-N-2047

Exploring the Scope of Dietary Supplement Ingredients

1 of your filingslast filed May 14, 20260 co-filers
FDANonrulemakingFDA-2025-D-1504

Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry; Availability

1 of your filingslast filed May 8, 20264 co-filers
FDANonrulemakingFDA-2026-N-0232

Medical Devices; Exemptions from Premarket Notification: Class II Devices; Request for Comments

1 of your filingslast filed Apr 9, 20260 co-filers
EPANonrulemakingEPA-HQ-OW-2025-3823

Review of Science on Fluoride in Drinking Water

1 of your filingslast filed Mar 2, 202653 co-filers
FDANonrulemakingFDA-2025-D-5107

Menstrual Products - Labeling and Performance Testing Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

1 of your filingslast filed Jan 21, 20260 co-filers
FDANonrulemakingFDA-2025-N-1793

Food Safety and Inspection Service Ultra-Processed Foods; Request for Information

1 of your filingslast filed Nov 21, 2025126 co-filers
FDANonrulemakingFDA-2025-P-4153

Requests that the FDA require revisions to the labeling for all over-the-counter acetaminophen-containing drug products marketed under the Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use monograph (OTC Monograph M013): (i) a revision to the “Warnings” subsection, currently found at M013.50(c)(1)(iii) in the Labeling section.

1 of your filingslast filed Nov 12, 202517 co-filers
FDANonrulemakingFDA-2025-N-2489

Onshoring Manufacturing of Drugs and Biological Products; Public Meeting; Request for Comments

1 of your filingslast filed Oct 31, 202517 co-filers
BISNonrulemakingBIS-2025-0258

Notice of Request for Public Comments on Section 232 National Security Investigation of Imports of Personal Protective Equipment, Medical Consumables, Medical Equipment, and Their Parts and Components

1 of your filingslast filed Oct 22, 2025202 co-filers
FDARulemakingFDA-2025-N-1360

Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs

1 of your filingslast filed Oct 9, 20251 co-filers
FDANonrulemakingFDA-2025-D-1358

Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs; Draft Guidance for Industry; Availability

1 of your filingslast filed Oct 9, 20250 co-filers
FDANonrulemakingFDA-2025-N-1733

Tool for the Prioritization of Food Chemicals for Post-Market Assessment

1 of your filingslast filed Aug 19, 202532 co-filers
FDANonrulemakingFDA-2025-N-0816

Reauthorization of the Prescription Drug User Fee Act; Public Meeting; Request for Comments

1 of your filingslast filed Aug 7, 20250 co-filers
FDARulemakingFDA-2025-N-1359

Over-the-Counter Monograph Condition B001: Single-Unit or Unit-Dose Containers for Over-the-Counter Monograph Drugs in Orally Disintegrating Tablet and Film Dosage Forms

1 of your filingslast filed Aug 5, 20251 co-filers
FDANonrulemakingFDA-2025-D-0507

Replacing Color Additives in Approved and Marketed Drug Products; Draft Guidance for Industry; Availability

1 of your filingslast filed Jul 30, 20251 co-filers
FDANonrulemakingFDA-2024-D-1528

Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers

1 of your filingslast filed Jul 18, 20251 co-filers
FDANonrulemakingFDA-2024-N-4734

Amending Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use

1 of your filingslast filed May 28, 20251 co-filers
BISNonrulemakingBIS-2025-0022

Notice of Request for Public Comments on Section 232 National Security Investigation of Imports of Pharmaceuticals and Pharmaceutical Ingredients

1 of your filingslast filed May 28, 2025212 co-filers
FDANonrulemakingFDA-2024-N-3609

Development of an Enhanced Systematic Process for FDA’s Post-Market Assessment of Chemicals in Food; Public Meeting; Request for Comments

1 of your filingslast filed Apr 9, 202532 co-filers
FDANonrulemakingFDA-2024-D-4689

Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request

1 of your filingslast filed Apr 8, 202532 co-filers
EPANonrulemakingEPA-HQ-OPPT-2018-0448

Vinyl Chloride; TSCA Review

1 of your filingslast filed Apr 8, 20255 co-filers
FDANonrulemakingFDA-2024-D-4488

Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

1 of your filingslast filed Apr 4, 20254 co-filers
FDARulemakingFDA-2023-N-4225

Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products

1 of your filingslast filed Mar 28, 20255 co-filers
EBSARulemakingEBSA-2024-0011

Enhancing Coverage of Preventive Services under the Affordable Care Act

1 of your filingslast filed Dec 30, 202429 co-filers
FDANonrulemakingFDA-2020-D-1530

Control of Nitrosamine Impurities in Human Drugs; Guidance for Industry; Availability

2 of your filingslast filed Dec 20, 20241 co-filers
FDANonrulemakingFDA-2024-D-2338

Predetermined Change Control Plans for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

1 of your filingslast filed Nov 20, 20241 co-filers
FDANonrulemakingFDA-2021-D-0789

Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry; Availability

1 of your filingslast filed Oct 31, 202487 co-filers
USTRNonrulemakingUSTR-2024-0013

2024 Special 301 Out-of-Cycle Review of Notorious Markets: Comment Request

1 of your filingslast filed Oct 3, 20244 co-filers
FDANonrulemakingFDA-2024-N-2561

Best Practices for Meeting Management; Public Workshop; Request for Comments

1 of your filingslast filed Aug 23, 20240 co-filers
FDANonrulemakingFDA-2024-N-1809

Listening Session: Optimizing FDA’s Use of and Processes for Advisory Committees; Public Meeting; Request for Comments

1 of your filingslast filed Aug 9, 202420 co-filers
FDANonrulemakingFDA-2024-N-2422

Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use

1 of your filingslast filed Aug 9, 20240 co-filers
CISARulemakingCISA-2022-0010

Cyber Incident Reporting for Critical Infrastructure Act (CIRCIA) Reporting Requirements

1 of your filingslast filed Jul 2, 2024155 co-filers
FDANonrulemakingFDA-2023-D-5470

Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products; Draft Guidance for Industry; Availability

1 of your filingslast filed Jun 17, 20240 co-filers
FDANonrulemakingFDA-2024-D-0706

New Dietary Ingredient Notification Master Files for Dietary Supplements; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Comment Request

1 of your filingslast filed May 28, 20240 co-filers
FDANonrulemakingFDA-2023-D-5616

Annual Reportable Labeling Changes for NDAs and ANDAs for Nonprescription Drug Products; Draft Guidance for Industry; Availability

1 of your filingslast filed May 20, 20240 co-filers
FDANonrulemakingFDA-2022-D-0810

Conducting Remote Regulatory Assessments—Questions and Answers; Draft Guidance for Industry; Availability

2 of your filingslast filed Mar 29, 20246 co-filers
FDANonrulemakingFDA-2023-N-5653

Food and Drug Administration’s Draft Report and Plan on Best Practices for Guidance; Availability

1 of your filingslast filed Mar 5, 20243 co-filers
FDARulemakingFDA-2023-N-3392

Medical Devices; General and Plastic Surgery Devices; Classification of Certain Solid Wound Dressings, Wound Dressings Formulated as a Gel, Creams, or Ointment, and Liquid Wound Washes

1 of your filingslast filed Feb 22, 20240 co-filers
FDANonrulemakingFDA-2023-D-4177

Quality Considerations for Topical Ophthalmic Drug Products; Draft Guidance for Industry; Availability

1 of your filingslast filed Dec 13, 20231 co-filers
EBSARulemakingEBSA-2023-0013

Request for Information; Coverage of Over-the-Counter Preventive Services

1 of your filingslast filed Dec 7, 202346 co-filers
FDANonrulemakingFDA-2023-N-3941

Advisory Committee; Digital Health Committee; Establishment

1 of your filingslast filed Nov 22, 20230 co-filers
FDARulemakingFDA-2023-N-2177

Medical Devices; Laboratory Developed Tests

1 of your filingslast filed Nov 17, 20232 co-filers
FDANonrulemakingFDA-2023-D-3133

Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

1 of your filingslast filed Nov 15, 20231 co-filers
FDANonrulemakingFDA-2023-N-3575

Reauthorization of the Over-the-Counter Monograph Drug User Fee program; Public Meeting; Request for Comments

1 of your filingslast filed Oct 27, 202310 co-filers
EPANonrulemakingEPA-HQ-OPPT-2023-0311

Stakeholder Engagement Opportunity for the Safer Choice and Design for the Environment (DfE) Programs’ Potential Expansion into New Product Categories

1 of your filingslast filed Oct 23, 202315 co-filers
FDANonrulemakingFDA-2023-D-1618

Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information; Draft Guidance for Industry; Availability

1 of your filingslast filed Sep 25, 20230 co-filers
FDANonrulemakingFDA-2023-N-2653

Nonprescription Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

1 of your filingslast filed Sep 11, 20233 co-filers
FDANonrulemakingFDA-2023-C-1487

Filing of Color Additive Petition From Environmental Defense Fund, et al.; Request To Revoke Color Additive Listing for Use of Titanium Dioxide in Food

1 of your filingslast filed Aug 30, 20231 co-filers
FDANonrulemakingFDA-2023-D-2204

Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability

1 of your filingslast filed Aug 23, 20230 co-filers
FDANonrulemakingFDA-2022-D-2628

Marketing Submission Recommendations for a Modification Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

1 of your filingslast filed Aug 21, 20233 co-filers
FDANonrulemakingFDA-2023-N-1956

FDA Seeks Public Comment: Increasing Patient Access to At-Home Use Medical Technologies

1 of your filingslast filed Aug 21, 20231 co-filers
FDANonrulemakingFDA-2023-N-1585

Identification, Assessment, and Control of Nitrosamine Drug Substance-Related Impurities in Human Drug Products; Establishment of a Public Docket; Request for Comments

1 of your filingslast filed Jul 5, 20232 co-filers
FDANonrulemakingFDA-2023-D-1188

Over-the-Counter Monograph Order Requests (OMORs): Format and Content; Draft Guidance for Industry; Availability

1 of your filingslast filed Jun 12, 20230 co-filers
FTCRulemakingFTC-2022-0077

FTC Seek Comments on Green Guides Review, Matter No. P954501

1 of your filingslast filed May 10, 2023141 co-filers
FDANonrulemakingFDA-1981-N-0015

Antigingivitis & Antiplaque-Related Claims

1 of your filingslast filed Apr 4, 20230 co-filers
FDANonrulemakingFDA-2020-N-0258

Investigational New Drug Application Annual Reporting

1 of your filingslast filed Mar 10, 20230 co-filers
FDANonrulemakingFDA-2019-N-2650

Investigational New Drug Applications; Exemptions for Clinical Investigations to Evaluate a Drug Use of a Product Lawfully Marketed as a Conventional Food, Dietary Supplement, or Cosmetic

1 of your filingslast filed Mar 9, 20230 co-filers
FDARulemakingFDA-2015-D-4599

List of Highest Priority Devices for Human Factors Review

1 of your filingslast filed Feb 21, 20231 co-filers
EPARulemakingEPA-HQ-TRI-2022-0270

Changes to Reporting Requirements for Per- and Polyfluoroalkyl Substances; Community Right-to-Know Toxic Chemical Release Reporting

1 of your filingslast filed Feb 7, 202324 co-filers
FDANonrulemakingFDA-2022-D-0099

Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request

1 of your filingslast filed Jan 31, 20230 co-filers
FDARulemakingFDA-2021-N-0862

Nonprescription Drug Product With an Additional Condition for Nonprescription Use; Proposed Rule

2 of your filingslast filed Nov 23, 202215 co-filers
FDANonrulemakingFDA-2021-D-0528

Quantifying Sodium, Potassium, and Phosphorus in Labeling for Human Over-the-Counter and Prescription Drug Products; Draft Guidance for Industry; Availability

2 of your filingslast filed Nov 15, 20220 co-filers
FDANonrulemakingFDA-2022-D-1837

Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products

1 of your filingslast filed Nov 9, 20220 co-filers
FDANonrulemakingFDA-2022-D-2059

Providing Over-the-Counter Monograph Submissions in Electronic Format; Draft Guidance for Industry; Availability

1 of your filingslast filed Nov 9, 20220 co-filers
FDARulemakingFDA-2021-N-1351

Revising the National Drug Code Format and Drug Label Barcode Requirements

1 of your filingslast filed Oct 5, 202219 co-filers
FDANonrulemakingFDA-2022-P-0896

Requests that the FDA issue the administrative order for the OTC external analgesics as deemed final by section 505G of the FD&C Act, and that the FDA confirm and clarify for which specific indications OTC external analgesic drug products in PPP dosage forms are generally recognized as safe and effective.

1 of your filingslast filed Aug 12, 20220 co-filers
FDANonrulemakingFDA-2022-D-0281

Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request

1 of your filingslast filed Jul 19, 20220 co-filers
FDANonrulemakingFDA-2021-D-1158

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

1 of your filingslast filed Jul 8, 20221 co-filers
FDANonrulemakingFDA-2022-N-0236

Prioritizing the Addition of Maximum Daily Exposure Information and Removing Dosage Form Information From the Inactive Ingredient Database; Establishment of a Public Docket; Request for Comments

1 of your filingslast filed Jun 24, 20220 co-filers
FDARulemakingFDA-2021-N-0507

Medical Devices; Quality System Regulation Amendments

1 of your filingslast filed May 24, 20221 co-filers
FDANonrulemakingFDA-2021-N-0556

Development of Non-Opioid Analgesics for Acute Pain; Draft Guidance for Industry; Availability

1 of your filingslast filed Apr 12, 20220 co-filers
FDANonrulemakingFDA-2022-D-0080

Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs; Draft Guidance for Industry; Availability

1 of your filingslast filed Apr 8, 20220 co-filers
FDANonrulemakingFDA-2021-P-0523

Requests that the FDA revert to its longstanding policy of allowing manufacturers to market dietary supplements containing NAC and rescind the legally invalid position included in warning letters11 that NAC is precluded by section 201(ff)(3)(B)(i) of the FDCA from being a legal dietary ingredient in dietary supplements; CLOSED

1 of your filingslast filed Jan 26, 20220 co-filers
FDANonrulemakingFDA-2020-D-1380

Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products: Guidance for Industry and FDA Staff

1 of your filingslast filed Jan 21, 20220 co-filers
FDANonrulemakingFDA-2021-N-0555

Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids and Aligning Other Regulations

1 of your filingslast filed Jan 18, 202261 co-filers
FDANonrulemakingFDA-2021-D-1031

Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act; Draft Guidance for Industry; Availability

1 of your filingslast filed Jan 7, 20223 co-filers
FDANonrulemakingFDA-2017-D-6821

Providing Comments on CDER Level 2 Guidances

1 of your filingslast filed Dec 30, 20212 co-filers
FDARulemakingFDA-1978-N-0018

Sunscreen Drug Products -OPEN

4 of your filingslast filed Dec 23, 202146 co-filers
FDANonrulemakingFDA-2017-D-6841

Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff; Availability

1 of your filingslast filed Dec 10, 20211 co-filers
FDANonrulemakingFDA-2021-D-0872

Electronic Submission Template for Medical Device 510(k) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

1 of your filingslast filed Nov 26, 20211 co-filers
FDANonrulemakingFDA-2020-D-2316

Benefit-Risk Assessment for New Drug and Biological Products; Draft Guidance for Industry; Availability

1 of your filingslast filed Nov 17, 20210 co-filers
FDANonrulemakingFDA-2021-N-0843

Genus Medical Technologies LLC Versus United States Food and Drug Administration; Request for Information and Comments

1 of your filingslast filed Nov 8, 20213 co-filers
FDANonrulemakingFDA-2020-D-0770

Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry; Availability

1 of your filingslast filed Jun 29, 20210 co-filers
FDANonrulemakingFDA-2020-D-1106

Policy for Compounding of Certain Alcohol-Based Hand Sanitizer Products Through April 30, 2020; Immediately in Effect Guidance for Industry

1 of your filingslast filed Apr 30, 202111 co-filers
BISNonrulemakingBIS-2020-0034

Condition of the Public Health Industrial Base and Recommend Policies and Actions to Strengthen the Public Health Industrial Base to Ensure Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States

1 of your filingslast filed Jan 8, 20212 co-filers
FDANonrulemakingFDA-2012-N-1021

Food and Drug User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Years Proposed Guidance Developments

1 of your filingslast filed Dec 4, 20202 co-filers
FDANonrulemakingFDA-2020-D-0567

Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products; Draft Guidance for Industry; Availability

1 of your filingslast filed May 19, 20200 co-filers
FDANonrulemakingFDA-2019-D-4447

Transdermal and Topical Delivery Systems - Product Development and Quality Considerations; Draft Guidance for Industry; Availability

1 of your filingslast filed Mar 3, 20200 co-filers
FDANonrulemakingFDA-2019-N-3453

Promoting Effective Drug Development Programs: Opportunities and Priorities for FDA’s Office of New Drugs; Public Meeting

1 of your filingslast filed Jan 8, 20200 co-filers
FDANonrulemakingFDA-2019-D-0298

Quality Considerations for Continuous Manufacturing; Draft Guidance for Industry

1 of your filingslast filed Aug 14, 20191 co-filers
FDANonrulemakingFDA-2019-P-0417

Requests that the FDA initiate all administrative and judicial action necessary to remove from the market, and to prevent the further marketing of lidocaine-containing drug products in patch, plaster, poultice, or comparable delivery systems that have not been approved pursuant to a new drug application or an abbreviated new drug application submitted under 21 U.S.C. § 355 and implementing

1 of your filingslast filed Jul 30, 20190 co-filers
FDANonrulemakingFDA-2019-N-1482

Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds; Public Hearing; Request for Comments

1 of your filingslast filed Jul 18, 201969 co-filers
FDANonrulemakingFDA-2019-N-1388

Responsible Innovation in Dietary Supplements; Public Meeting; Request for Comments

1 of your filingslast filed Jul 17, 20190 co-filers
FDANonrulemakingFDA-2018-D-2074

Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C: Draft Guidance for Industry and FDA Staff

1 of your filingslast filed Jul 11, 20192 co-filers
FDANonrulemakingFDA-2019-N-1468

Characterizing FDA’s Approach to Benefit-Risk Assessment Throughout the Medical Product Life Cycle; Public Meeting; Request for Comments

1 of your filingslast filed Jun 17, 20190 co-filers
FDANonrulemakingFDA-2018-N-4000

Framework for a Real-World Evidence Program; Availability

1 of your filingslast filed Apr 18, 20190 co-filers
FDANonrulemakingFDA-2019-D-0297

Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products; Draft Guidance for Industry

1 of your filingslast filed Apr 12, 20190 co-filers
FDANonrulemakingFDA-2018-N-4751

Modernizing FDA’s 510(k) Program; Establishment of a Public Docket; Request for Comments

1 of your filingslast filed Apr 8, 20192 co-filers
FDANonrulemakingFDA-2018-D-3443

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

1 of your filingslast filed Mar 15, 20192 co-filers
FDANonrulemakingFDA-2018-N-3017

Prescription Drug-Use-Related Software; Establishment of a Public Docket; Request for Comments

1 of your filingslast filed Feb 11, 20195 co-filers
FDANonrulemakingFDA-2018-N-2610

Future Format of the National Drug Code; Public Hearing; Request for Comments

1 of your filingslast filed Jan 8, 20199 co-filers
FDANonrulemakingFDA-2018-D-3304

The Special 510(k) Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

1 of your filingslast filed Nov 30, 20181 co-filers
FDANonrulemakingFDA-2018-P-2025

Requests that the FDA ban the use of oxybenzone and octinoxate in sunscreen and personal care products

1 of your filingslast filed Nov 26, 20180 co-filers
FDANonrulemakingFDA-2011-D-0376

Dietary Supplements: New Dietary Ingredient Notifications and Related Issues

4 of your filingslast filed Nov 8, 20180 co-filers
FDANonrulemakingFDA-2018-D-2281

Innovative Approaches for Nonprescription Drug Products; Draft Guidance for Industry; Availability

1 of your filingslast filed Sep 19, 20186 co-filers
FDANonrulemakingFDA-2018-D-1456

Maximal Usage Trials for Topical Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations; Draft Guidance for Industry; Availability

1 of your filingslast filed Jul 25, 20180 co-filers
FDANonrulemakingFDA-2018-D-1339

Multiple Function Software Device Products: Policy and Considerations

2 of your filingslast filed Jul 6, 20182 co-filers
FDANonrulemakingFDA-2017-D-6580

Drug Products Labeled as Homeopathic

1 of your filingslast filed May 22, 201878 co-filers
USTRNonrulemakingUSTR-2018-0005

Notice of Determination and Request for Public Comment Concerning Proposed Determination of Action Pursuant to Section 301

1 of your filingslast filed May 11, 2018263 co-filers
FDANonrulemakingFDA-2017-N-6529

FDA’s Approach to Evaluating Nicotine Replacement Therapies; Public Hearing; Request for Comments

1 of your filingslast filed Mar 5, 20189 co-filers
FDANonrulemakingFDA-2017-N-5094

Review of Existing Center for Food Safety and Applied Nutrition Regulatory and Information Collection Requirements

1 of your filingslast filed Feb 13, 20184 co-filers
FDANonrulemakingFDA-2017-N-5101

Review of Existing Center for Drug Evaluation and Research Regulatory and Information Collection Requirements

1 of your filingslast filed Feb 8, 20182 co-filers
FDANonrulemakingFDA-2017-N-5105

Review of Existing Center for Devices and Radiological Health Regulatory and Information Collection Requirements

1 of your filingslast filed Feb 8, 201813 co-filers
FDANonrulemakingFDA-2017-N-4625

Development of a List of Pre-DSHEA Dietary Ingredients

1 of your filingslast filed Dec 7, 20170 co-filers
FDANonrulemakingFDA-2017-P-2733

Requests that the FDA require a new warning concerning the risk of esophageal cancer for all over-the-counter (“OTC”) drug products that are labeled to relieve or prevent heartburn associated with reflux disease, acid indigestion and sour stomach

1 of your filingslast filed Jul 19, 20170 co-filers
EPANonrulemakingEPA-HQ-OA-2017-0190

Evaluation of Existing Regulations

1 of your filingslast filed Jun 14, 2017481 co-filers
FDANonrulemakingFDA-2015-D-2537

Request for Quality Metrics

2 of your filingslast filed Apr 3, 20172 co-filers
FDANonrulemakingFDA-2016-D-3401

Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30)

1 of your filingslast filed Feb 15, 20171 co-filers
FDANonrulemakingFDA-2016-N-3389

Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates

1 of your filingslast filed Feb 15, 20171 co-filers
FDANonrulemakingFDA-2016-N-2523

Request for Comment on the Status of Vinpocetine

1 of your filingslast filed Nov 16, 20160 co-filers
FDANonrulemakingFDA-2014-N-1207

Use of the Term "Natural" in the Labeling of Human Food Products

1 of your filingslast filed Nov 3, 201673 co-filers
FDANonrulemakingFDA-2000-D-0277

Allergic Rhinitis: Clinical Development Programs for Drug

1 of your filingslast filed Sep 1, 20160 co-filers
FDANonrulemakingFDA-2015-P-4131

Petitioner requesting FDA to issue a final rule removing oral phenylephrine from the Final Monograph for OTC nasal decongestant drug products and to remove phenylephrine bitartrate from the 2006 amendment.

1 of your filingslast filed Aug 31, 20162 co-filers
FDARulemakingFDA-1998-N-0051

Over the Counter Human Drugs Labeling Requirements

4 of your filingslast filed Aug 22, 20160 co-filers
FDANonrulemakingFDA-2016-D-1490

Quality Attribute Considerations for Chewable Tablets

1 of your filingslast filed Aug 19, 20160 co-filers
FDANonrulemakingFDA-1998-N-0009

Definition and Option of Alternative Labeling Requirements for Convenience Size OTC Drug Packages

2 of your filingslast filed Aug 4, 20160 co-filers
FDARulemakingFDA-2016-N-0543

Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications

1 of your filingslast filed Jun 2, 20160 co-filers
FDARulemakingFDA-2015-N-1260

Fixed-Combination and Co-Packaged Drugs and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph

1 of your filingslast filed May 10, 20160 co-filers
FDANonrulemakingFDA-2016-D-0236

Nonallergic Rhinitis: Developing Drug Products for Treatment

1 of your filingslast filed Apr 18, 20160 co-filers
FDANonrulemakingFDA-2015-D-4021

Over-the-Counter Sunscreens: Safety and Effectiveness Data

2 of your filingslast filed Feb 23, 201611 co-filers
FDANonrulemakingFDA-2003-N-0313

Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products

2 of your filingslast filed Feb 9, 20166 co-filers
FDANonrulemakingFDA-2015-D-4012

Sunscreen Innovation Act; Withdrawal of a 586A Request or Pending Request

1 of your filingslast filed Jan 21, 20160 co-filers
FDANonrulemakingFDA-2015-D-3990

Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process

1 of your filingslast filed Jan 21, 20160 co-filers
FDANonrulemakingFDA-2015-D-4033

Sunscreen Innovation Act: Nonprescription Sunscreen Drug Products Content and Format of Data Submissions

1 of your filingslast filed Jan 21, 20160 co-filers
EPARulemakingEPA-HQ-RCRA-2007-0932

Amendment to the Universal Waste Rule: Addition of Pharmaceuticals

2 of your filingslast filed Jan 5, 201675 co-filers
FDANonrulemakingFDA-2013-N-0878

Premarket Notification for a New Dietary Ingredient

1 of your filingslast filed Dec 1, 20150 co-filers
FDANonrulemakingFDA-1999-D-1315

Formal Meetings with Sponsors and Applicant for Prescription Drug User Fee Act (PDUFA) Products

1 of your filingslast filed Oct 1, 20150 co-filers
FDANonrulemakingFDA-2011-N-0915

Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application

1 of your filingslast filed Sep 11, 20150 co-filers
FDANonrulemakingFDA-2014-D-1862

Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions

1 of your filingslast filed Aug 25, 20150 co-filers
FDARulemakingFDA-1996-N-0006

Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System

1 of your filingslast filed Jul 7, 201511 co-filers
FDANonrulemakingFDA-2005-N-0453

Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients

1 of your filingslast filed Feb 23, 20150 co-filers
FDANonrulemakingFDA-2014-D-1473

Over-the-Counter Pediatric Oral Liquid Drug Products Containing Acetaminophen

1 of your filingslast filed Feb 3, 20152 co-filers
FDANonrulemakingFDA-2014-N-1008

Exploring the Possibility of Proprietary Name Reservation for Drug Products Establishment of a Public Docket

1 of your filingslast filed Nov 20, 20140 co-filers
FDARulemakingFDA-2012-N-1210

Food Labeling: Revision of the Nutrition and Supplement Facts Labels

1 of your filingslast filed May 14, 2014111 co-filers
FDANonrulemakingFDA-2014-N-0202

Over-The-Counter Drug Monograph System — Past, Present, and Future; Public Hearing

1 of your filingslast filed May 13, 20148 co-filers
FDANonrulemakingFDA-2010-D-0503

Investigational New Drug Applications (INDs)—Determining Whether Human Research Studies Can Be Conducted Without an IND

2 of your filingslast filed Apr 17, 20142 co-filers
FDARulemakingFDA-2013-N-0500

Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products

1 of your filingslast filed Mar 25, 201431 co-filers
FDANonrulemakingFDA-2003-N-0426

Over-the-Counter Drug Products; Safety & Efficacy Review

1 of your filingslast filed Feb 21, 20140 co-filers
FDARulemakingFDA-2003-N-0196

Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients

1 of your filingslast filed Feb 14, 20140 co-filers
FDANonrulemakingFDA-2013-N-0032

Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements

1 of your filingslast filed Mar 21, 20130 co-filers
FDARulemakingFDA-2011-N-0090

Unique Device Identification System

1 of your filingslast filed Nov 13, 201272 co-filers
USTRNonrulemakingUSTR-2012-0028

US-EU Regulatory Compatability

1 of your filingslast filed Nov 2, 201243 co-filers
FDANonrulemakingFDA-2012-N-0171

Using Innovative Technologies and Other Conditions of Safe Use To Expand Which Drug Products Can Be Considered Nonprescription

1 of your filingslast filed May 15, 201221 co-filers
FDANonrulemakingFDA-2011-N-0842

Gluten in Drug Products; Request for Information and Comments

1 of your filingslast filed Mar 29, 20125 co-filers
CMSRulemakingCMS-2011-0191

Medicare, Medicaid, Children's Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests (CMS-5060-P)

1 of your filingslast filed Feb 17, 2012106 co-filers
FDANonrulemakingFDA-2011-D-0620

Draft Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products; Availability

1 of your filingslast filed Dec 22, 20110 co-filers
FDANonrulemakingFDA-2010-N-0128

Prescription Drug User Fee Act

1 of your filingslast filed Nov 4, 201146 co-filers
FDANonrulemakingFDA-2010-D-0530

Draft Guidance for Industry on Principles for Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology; Availability

1 of your filingslast filed Aug 24, 20110 co-filers
FDANonrulemakingFDA-2011-N-0002

Advisory Committee, Workshops, and Conferences Notices Various Meeting Notices (eg., Task Force Meeting, etc.)

1 of your filingslast filed Jun 27, 20110 co-filers
FDANonrulemakingFDA-2011-N-0144

Section 302. Voluntary Qualified Importer Program

1 of your filingslast filed May 23, 20113 co-filers
FDARulemakingFDA-2011-N-0146

Accreditation of Third-Party Auditors

1 of your filingslast filed May 10, 20113 co-filers
FDANonrulemakingFDA-2011-N-0145

Section 303. Authority to Require Import Certifications for Food

1 of your filingslast filed May 6, 20113 co-filers
FDARulemakingFDA-2011-N-0143

Foreign Supplier Verification Program

1 of your filingslast filed May 5, 2011102 co-filers
FDANonrulemakingFDA-2011-N-0134

FDA Food Safety Modernization Act: Title III—A New Paradigm for Importers; Public Meeting

1 of your filingslast filed May 5, 20111 co-filers
FDANonrulemakingFDA-2006-P-0033

Health Claim: Phytosterols & Reduced Risk of Coronary Heart Disease CLOSED 05/26/2020

1 of your filingslast filed Feb 8, 20110 co-filers
FDANonrulemakingFDA-2000-P-0133

Health Claim: Plant Stanol Esters and Heart Disease CLOSED 05/26/2020

1 of your filingslast filed Feb 8, 20110 co-filers
FDANonrulemakingFDA-2000-P-0102

Health Claim: Vegetable Oil Sterol Esters & Coronary Heart Disease CLOSED 05/26/2020

1 of your filingslast filed Feb 8, 20110 co-filers
FDANonrulemakingFDA-1978-N-0022

Over-the-Counter (OTC) External Analgesic Drug Products- OPEN

1 of your filingslast filed Apr 30, 20100 co-filers
FDANonrulemakingFDA-2009-D-0322

Guidance for Industry on Dosage Delivery Devices for OTC Liquid Drug Products; Availability”

1 of your filingslast filed Feb 2, 20100 co-filers
FDANonrulemakingFDA-2009-N-0247

FDA Transparency Task Force; Public Meeting

1 of your filingslast filed Nov 13, 200952 co-filers
FDANonrulemakingFDA-1996-N-0028

Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Supplements

4 of your filingslast filed Oct 21, 200971 co-filers
FDANonrulemakingFDA-2009-D-0181

Draft Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products

1 of your filingslast filed Aug 5, 20090 co-filers
FDANonrulemakingFDA-2009-N-0138

Joint Meeting of the Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee; Notice of Meeting.

1 of your filingslast filed Jun 10, 200918 co-filers
FDANonrulemakingFDA-2005-N-0464

Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs

4 of your filingslast filed Apr 15, 20094 co-filers
FDANonrulemakingFDA-2007-D-0209

Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act

2 of your filingslast filed Jan 16, 20090 co-filers
FDANonrulemakingFDA-2007-D-0429

Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act

2 of your filingslast filed Jan 14, 20090 co-filers
FDANonrulemakingFDA-2008-N-0466

Over-the-Counter Cough and Cold Medications for Pediatric Use; Notice of Public Hearing

1 of your filingslast filed Dec 3, 20082 co-filers
FDANonrulemakingFDA-2006-N-0414

Supplements and Other Changes to an Approved Application

1 of your filingslast filed Nov 15, 20080 co-filers
FDANonrulemakingFDA-2008-N-0416

Consideration of FDA-Regulated Products that May Contain Nanoscale Materials; Public Meeting and Data Call

1 of your filingslast filed Oct 29, 20081 co-filers
FDANonrulemakingFDA-2008-N-0448

International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Gamma-hydroxybutyric acid (GHB); Ketamine; Dextromethorphan; N-benzylpiperazine (BZP); 1-(3-trifluoromethylphenyl)piperazine (TFMPP); 1-(3-chlorophenyl)piperazine (mCPP); 1-(4-Methoxyphenyl)piperazine (MeOPP); 1-(3,4-methylenedioxybenzyl)piperazine (MDBP); Gamma-butyrolactone; 1,4-Butanediol

1 of your filingslast filed Oct 28, 20082 co-filers
FDANonrulemakingFDA-1976-N-0027

OTC Nasal Decongestants

3 of your filingslast filed Oct 16, 20080 co-filers
FDANonrulemakingFDA-1977-N-0013

Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling - OPEN

1 of your filingslast filed Oct 7, 20081 co-filers
FDARulemakingFDA-1978-N-0023

Skin Bleaching Drug Products- OPEN

1 of your filingslast filed Oct 6, 20080 co-filers
FDANonrulemakingFDA-2008-N-0281

Pilot Program To Evaluate Proposed Name Submissions; Concept Paper; Public Meeting,

1 of your filingslast filed Jul 7, 20086 co-filers
FDARulemakingFDA-2008-N-0040

Food Labeling: Revision of Reference Values and Mandatory Nutrients; Extension of Comment Period

1 of your filingslast filed May 1, 20084 co-filers
FDANonrulemakingFDA-1981-N-0013

Oral Health Care Drug Products for OTC Human Use

2 of your filingslast filed Mar 1, 20060 co-filers
FHWARulemakingFHWA-2004-17321

National Standards for Traffic Control Devices; the Manual on Uniform Traffic Control Devices for Streets and Highways; Specific Service and General Service Signing for 24-Hours Parmarcies

1 of your filingslast filed Jun 22, 200416 co-filers

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