American Pharmacists Association (APhA)
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140
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2215 Constitution Avenue Northwest, Washington, DC
Phone
+1 202-628-4410
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pharmacist.comEngagement overview
American Pharmacists Association (APhA) has filed 230 public comments across 202 dockets at 17 federal agencies, most actively at the Food and Drug Administration.
230
Comments filed
202
Dockets engaged
17
Agencies
Jul 21, 2026
Last filing
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Agency footprint
Dockets · FDA (140)
sorted by most recent filingFDANonrulemakingFDA-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 Jul 21, 202617 co-filers
FDANonrulemakingFDA-2026-N-4492
Drug Repurposing for Unmet Medical Needs; Request for Information
1 of your filingslast filed Jul 15, 202661 co-filers
FDANonrulemakingFDA-2025-N-6895
Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments--Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List
1 of your filingslast filed Jul 10, 202631 co-filers
FDANonrulemakingFDA-2026-N-3962
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments – United States (U.S.) 2026-2027 Formula for COVID-19 Vaccine Composition.
1 of your filingslast filed May 29, 20260 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-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Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry; Availability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-1001
Developing Specifications for In-Home Disposal Systems for Opioid Analgesics Dispensed in an Outpatient Setting; Establishment of a Public Docket; Request for Comments
1 of your filingslast filed Apr 10, 20263 co-filers
FDANonrulemakingFDA-2026-N-0826
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments – United States (U.S.) 2026-2027 Influenza Vaccine Strain Composition
1 of your filingslast filed Mar 4, 20264 co-filers
FDANonrulemakingFDA-2025-N-6743
Food and Drug Administration Expert Panel on Testosterone Replacement Therapy for Men; Request for Information
1 of your filingslast filed Feb 20, 202611 co-filers
FDANonrulemakingFDA-2025-N-4348
Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
1 of your filingslast filed Jan 28, 20264 co-filers
FDANonrulemakingFDA-2025-N-6494
Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use
1 of your filingslast filed Jan 28, 20265 co-filers
FDANonrulemakingFDA-2025-N-2976
Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine; Public Workshop; Request for Comments
1 of your filingslast filed Jan 21, 20261 co-filers
FDANonrulemakingFDA-2024-N-0668
Agency Information Collection Activities; Proposed Collection; Comment Request; Proposed Small Dispensers Assessment under the Drug Supply Chain Security Act
2 of your filingslast filed Dec 18, 20251 co-filers
FDARulemakingFDA-2015-N-0030
Compounding of Human Drug Products Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket
1 of your filingslast filed Nov 6, 202527 co-filers
FDANonrulemakingFDA-2025-N-0082
Agency Information Collection Activities; Proposed Collection; Comment Request; Compounding Animal Drugs from Bulk Drug Substances
2 of your filingslast filed Aug 22, 20252 co-filers
FDANonrulemakingFDA-2025-N-1557
Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population; Public Meeting; Establishment of a Public Docket; Request for Comments
1 of your filingslast filed Aug 15, 202517 co-filers
FDANonrulemakingFDA-2025-N-1146
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments -- 2025-2026 formula for COVID-19 vaccines for use in the United States: Meeting Date: May 22, 2025.
1 of your filingslast filed May 19, 202531 co-filers
FDARulemakingFDA-2019-N-5959
Medication Guides: Patient Medication Information; Proposed Rule
1 of your filingslast filed Mar 13, 202423 co-filers
FDANonrulemakingFDA-2023-N-4806
Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket; Request for Information and Comments
2 of your filingslast filed Feb 21, 20248 co-filers
FDANonrulemakingFDA-2023-N-4853
CDRH Seeks public comment: Digital Health Technologies for Detecting Prediabetes and Undiagnosed Type 2 Diabetes
1 of your filingslast filed Feb 1, 20244 co-filers
FDARulemakingFDA-2015-D-3517
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the FD&C Act
1 of your filingslast filed Jan 9, 20248 co-filers
FDANonrulemakingFDA-2016-D-0643
Labeling for Biosimilar Products
2 of your filingslast filed Nov 20, 202330 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
FDANonrulemakingFDA-2023-N-3103
Development of Small Dispensers Assessment under the Drug Supply Chain Security Act; Request for Comments
1 of your filingslast filed Sep 8, 20232 co-filers
FDANonrulemakingFDA-2023-N-0917
In-Home Safe Disposal Systems; Request for Information
1 of your filingslast filed Aug 29, 202311 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 Aug 29, 20233 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 28, 20232 co-filers
FDANonrulemakingFDA-2022-N-3245
Joint Meeting of the Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
1 of your filingslast filed Feb 13, 20232 co-filers
FDANonrulemakingFDA-2022-N-2671
DSCSA Implementation and Readiness Efforts for 2023; Public Meeting; Request for Comments
1 of your filingslast filed Feb 6, 20234 co-filers
FDANonrulemakingFDA-2014-D-1981
DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information; Availability
2 of your filingslast filed Dec 9, 20227 co-filers
FDARulemakingFDA-2021-N-0862
Nonprescription Drug Product With an Additional Condition for Nonprescription Use; Proposed Rule
1 of your filingslast filed Nov 25, 202215 co-filers
FDARulemakingFDA-2021-N-1351
Revising the National Drug Code Format and Drug Label Barcode Requirements
1 of your filingslast filed Nov 23, 202219 co-filers
FDANonrulemakingFDA-2017-D-1956
Identifying Trading Partners Under the Drug Supply Chain Security Act
1 of your filingslast filed Sep 7, 20229 co-filers
FDANonrulemakingFDA-2020-N-1663
National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers
1 of your filingslast filed Sep 7, 202220 co-filers
FDANonrulemakingFDA-2022-N-0165
Providing Mail-Back Envelopes and Education on Safe Disposal With Opioid Analgesics Dispensed in an Outpatient Setting; Establishment of a Public Docket; Request for Comments
1 of your filingslast filed Jun 22, 202223 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 20, 202261 co-filers
FDANonrulemakingFDA-2020-N-1459
Generic Drug User Fee Amendments; Public Meeting; Request for Comments
2 of your filingslast filed Dec 13, 20212 co-filers
FDANonrulemakingFDA-2016-D-0271
Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act
2 of your filingslast filed Dec 7, 202126 co-filers
FDANonrulemakingFDA-2015-N-3326
Biosimilar User Fee Act
1 of your filingslast filed Dec 6, 202113 co-filers
FDANonrulemakingFDA-2021-N-0951
Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS) in an Evolving Opioid Crisis; Public Workshop; Request for Comments
1 of your filingslast filed Dec 6, 20218 co-filers
FDANonrulemakingFDA-2021-N-0891
Reauthorization of the Prescription Drug User Fee Act; Public Meeting; Request for Comments
1 of your filingslast filed Oct 29, 202113 co-filers
FDANonrulemakingFDA-2020-D-2024
Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act
1 of your filingslast filed Sep 3, 202112 co-filers
FDANonrulemakingFDA-2018-D-0338
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act
2 of your filingslast filed Aug 18, 20216 co-filers
FDANonrulemakingFDA-2020-N-1862
The Drug Supply Chain Security Act Pilot Project Program and Enhanced Drug Distribution Security; Public Meeting; Request for Comments
1 of your filingslast filed Jun 25, 20216 co-filers
FDANonrulemakingFDA-2021-Z-0025
Dual Agency - HHS Federal Register Notices (FRN) without a docket ID which includes FDA data or supported related material
1 of your filingslast filed May 17, 20214 co-filers
FDANonrulemakingFDA-2021-P-0034
Covington & Burling LLP on behalf of PhRMA, PSM and CAHC respectfully request that the U.S. Food and Drug Administration refrain from authorizing the Proposal and disclose the identities of Foreign Sellers for public comments
1 of your filingslast filed Apr 1, 20212 co-filers
FDANonrulemakingFDA-2019-N-1845
Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate-Release Opioid Analgesics for Treatment of Acute Pain; Establishment of a Public Docket; Request for Comments
2 of your filingslast filed Feb 2, 202115 co-filers
FDANonrulemakingFDA-2020-N-1845
Risk Evaluation and Mitigation Strategy Assessment Summary for Web Posting; Establishment of a Public Docket; Request for Comments
1 of your filingslast filed Jan 5, 20211 co-filers
FDANonrulemakingFDA-2020-N-1069
Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book); Establishment of a Public Docket; Request for Comments
1 of your filingslast filed Sep 1, 20204 co-filers
FDANonrulemakingFDA-2010-N-0128
Prescription Drug User Fee Act
3 of your filingslast filed Jul 30, 202046 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
2 of your filingslast filed Mar 27, 202011 co-filers
FDANonrulemakingFDA-2019-N-5711
Importation of Prescription Drugs
1 of your filingslast filed Mar 9, 202063 co-filers
FDANonrulemakingFDA-2019-D-5743
Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry; Availability
1 of your filingslast filed Mar 3, 20209 co-filers
FDANonrulemakingFDA-2019-D-5255
Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products; Draft Guidance for Industry; Availability
1 of your filingslast filed Jan 28, 20205 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-1132
The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products; Date for Public Hearing; Request for Comments
1 of your filingslast filed Jun 5, 20195 co-filers
FDANonrulemakingFDA-2013-D-1543
Nonproprietary Naming of Biological Products
2 of your filingslast filed May 9, 201958 co-filers
FDANonrulemakingFDA-2018-D-4628
REMS Assessment: Planning and Reporting; Draft Guidance for Industry; Availability
1 of your filingslast filed Mar 29, 20194 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-D-3462
Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Draft Guidance for Industry; Availability
1 of your filingslast filed Feb 5, 20196 co-filers
FDANonrulemakingFDA-2018-N-3272
Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions; Public Meeting; Request for Comments
1 of your filingslast filed Jan 30, 201928 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-2016-D-2268
Insanitary Conditions at Compounding Facilities
2 of your filingslast filed Dec 18, 201821 co-filers
FDANonrulemakingFDA-2018-N-3065
Memorandum of Understanding Addressing Certain Distributions of Compounded Drug Products Between the States and the Food and Drug Administration; Revised Draft; Availability
1 of your filingslast filed Dec 14, 201811 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-1895
Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products -- Content and Format; Draft Guidance for Industry; Availability
1 of your filingslast filed Sep 6, 20181 co-filers
FDANonrulemakingFDA-2018-D-1043
Waivers of the Single, Shared System Risk Evaluation and Mitigation Strategy Requirement
1 of your filingslast filed Aug 28, 20186 co-filers
FDANonrulemakingFDA-2018-D-1041
Development of a Shared System Risk Evaluation and Mitigation Strategy
1 of your filingslast filed Aug 3, 20185 co-filers
FDANonrulemakingFDA-2018-N-1910
Fulfillment of 21st Century Cures Act Section 3060 Required Report
1 of your filingslast filed Jul 18, 201813 co-filers
FDANonrulemakingFDA-2018-D-1434
Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability.
1 of your filingslast filed Jul 11, 20183 co-filers
FDANonrulemakingFDA-2017-D-6580
Drug Products Labeled as Homeopathic
1 of your filingslast filed May 22, 201878 co-filers
FDANonrulemakingFDA-2017-N-6502
Opioid Policy Steering Committee prescribing intervention – exploring a strategy for implementation; Public Hearing; Request for Comments
1 of your filingslast filed Mar 27, 201821 co-filers
FDANonrulemakingFDA-2017-N-3857
Enhanced Drug Distribution Security under the Drug Supply Chain Security Act; Public Meetings; Request for Comments
2 of your filingslast filed Feb 14, 20185 co-filers
FDANonrulemakingFDA-2017-D-6526
DSCSA Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier
1 of your filingslast filed Jan 26, 20185 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 Dec 13, 201713 co-filers
FDANonrulemakingFDA-2009-D-0461
Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications
3 of your filingslast filed Dec 8, 201719 co-filers
FDANonrulemakingFDA-2017-N-2936
Content of Risk Information in the Major Statement in Prescription Drug Direct-to-Consumer Broadcast Advertisements; Request for Information and Comments
1 of your filingslast filed Nov 21, 20176 co-filers
FDANonrulemakingFDA-2016-N-0407
Proposed Pilot Project(s) under the Drug Supply Chain Security Act
2 of your filingslast filed Sep 19, 20176 co-filers
FDANonrulemakingFDA-2017-N-3615
Administering the Hatch-Waxman Amendments: Ensuring an Appropriate Balance Between Innovation and Access
1 of your filingslast filed Sep 19, 201724 co-filers
FDANonrulemakingFDA-2017-N-2903
Data and Methods for Evaluating the Impact of Opioid Formulations with Properties Designed to Deter Abuse in the Postmarket Setting: A Scientific Discussion of Present and Future Capabilities; Public Workshop; Issues Paper; Request for Comments
1 of your filingslast filed Sep 12, 20171 co-filers
FDANonrulemakingFDA-2017-D-2232
Product Identifier Requirements Under the Drug Supply Chain Security Act-Compliance Policy
1 of your filingslast filed Sep 6, 20178 co-filers
FDANonrulemakingFDA-2017-D-2497
FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids
1 of your filingslast filed Jul 12, 201720 co-filers
FDANonrulemakingFDA-2017-N-1094
Training for Opioid Analgesic Prescribers--Exploring the Path Forward
1 of your filingslast filed Jul 7, 201710 co-filers
FDANonrulemakingFDA-2016-D-1307
Questions and Answers Regarding Drug and Device Manufacturer Communications with Payors; Draft Guidance for Industry; Availability
1 of your filingslast filed Apr 20, 20179 co-filers
FDANonrulemakingFDA-2016-D-2285
Medical Product Communications that are Consistent with the FDA-required Labeling --Questions and Answers; Draft Guidance for Industry; Availability
1 of your filingslast filed Apr 20, 20176 co-filers
FDANonrulemakingFDA-2016-N-1149
Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products
1 of your filingslast filed Apr 20, 201713 co-filers
FDANonrulemakingFDA-2016-D-4318
Compounding and Repackaging of Radiopharmaceuticals By State-Licensed Nuclear Pharmacies and Federal Facilities; Draft Guidance for Industry; Availability
1 of your filingslast filed Feb 27, 20175 co-filers
FDANonrulemakingFDA-2016-D-2730
FDA's Application of Statutory Factors in Determining When a REMS Is Necessary
1 of your filingslast filed Dec 19, 20161 co-filers
FDANonrulemakingFDA-2016-N-2873
Workshop on Promoting Semantic Interoperability of Laboratory Data; Public Workshop; Request for Comments
1 of your filingslast filed Dec 14, 20161 co-filers
FDANonrulemakingFDA-2016-N-2673
Public Meeting on Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act
1 of your filingslast filed Dec 8, 20167 co-filers
FDANonrulemakingFDA-2016-D-1233
Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics; Draft Guidance for Stakeholders and Food and Drug Administration Staff; Availability
1 of your filingslast filed Oct 18, 201615 co-filers
FDANonrulemakingFDA-2016-D-1309
Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
1 of your filingslast filed Oct 12, 201610 co-filers
FDANonrulemakingFDA-2016-D-1270
Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases
1 of your filingslast filed Oct 12, 201613 co-filers
FDANonrulemakingFDA-2016-D-1673
Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn
1 of your filingslast filed Sep 21, 20163 co-filers
FDANonrulemakingFDA-2016-N-1660
Microbiology Devices Panel of the Medical Devices Advisory Committee
1 of your filingslast filed Sep 21, 20160 co-filers
FDANonrulemakingFDA-2016-D-0269
Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act
1 of your filingslast filed Aug 4, 201622 co-filers
FDANonrulemakingFDA-2016-N-0820
Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee
1 of your filingslast filed Jun 6, 20169 co-filers
FDANonrulemakingFDA-2016-N-1114
Pharmaceutical Distribution Supply Chain Pilot Projects
1 of your filingslast filed Jun 2, 20163 co-filers
FDANonrulemakingFDA-2015-N-4809
Patient and Medical Professional Perspectives on the Return of Genetic Test Results
1 of your filingslast filed Apr 21, 201610 co-filers
FDANonrulemakingFDA-2003-N-0313
Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products
1 of your filingslast filed Feb 9, 20166 co-filers
FDANonrulemakingFDA-2013-N-0502
Standardizing and Evaluating Risk Evaluation and Mitigation Strategies
1 of your filingslast filed Dec 4, 201527 co-filers
FDANonrulemakingFDA-2013-D-1067
Guidance for Industry on Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products--Content and Format; Availability
1 of your filingslast filed Nov 27, 20152 co-filers
FDARulemakingFDA-2015-N-0648
Designation of Official Names and Proper Names for Certain Biological Products
1 of your filingslast filed Nov 12, 201513 co-filers
FDANonrulemakingFDA-2011-N-0802
Role of Naloxone in Opioid Overdose Fatality Prevention; Public Workshop; Request for Comments
1 of your filingslast filed Sep 11, 201511 co-filers
FDANonrulemakingFDA-2014-N-1459
Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the States and the Food and Drug Administration
2 of your filingslast filed Aug 5, 20159 co-filers
FDARulemakingFDA-2007-N-0363
Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
2 of your filingslast filed Jun 2, 201523 co-filers
FDANonrulemakingFDA-2014-N-0337
Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format; Public Workshop; Request for Comments
1 of your filingslast filed May 1, 20155 co-filers
FDANonrulemakingFDA-2014-D-0609
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification
1 of your filingslast filed May 1, 201510 co-filers
FDANonrulemakingFDA-2014-N-1359
Development and Regulation of Abuse-Deterrent Formulations of Opioid Medications; Public Meeting
1 of your filingslast filed Jan 27, 20158 co-filers
FDANonrulemakingFDA-2013-P-1398
Require That a Biosimilar be Identified by the Same International Nonproprietary Name as the Reference Product
1 of your filingslast filed Mar 26, 20142 co-filers
FDANonrulemakingFDA-2013-P-1153
Requests That the International Non-Proprietary Naming (INN) Policy Equally to all Biologics
1 of your filingslast filed Mar 26, 20146 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-2013-D-1444
Pharmacy Compounding of Human Drug Products under Section 503A of the Federal Food, Drug, and Cosmetic Act
1 of your filingslast filed Feb 6, 20147 co-filers
FDANonrulemakingFDA-2012-N-1154
Framework for Pharmacy Compounding: State and Federal Roles
1 of your filingslast filed Jan 24, 201319 co-filers
FDANonrulemakingFDA-2012-N-0408
Risk Evaluation and Mitigation Strategy Assessments: Social Science Methodologies to Assess Goals Related to Knowledge; Public Workshop; Issue Paper
1 of your filingslast filed Jul 19, 20126 co-filers
FDANonrulemakingFDA-2011-D-0618
Draft Guidances Relating to the Development of Biosimilar Products; Public Hearing; Request for Comments
1 of your filingslast filed May 30, 201210 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-0690
Center for Drug Evaluation and Research, Approach to Addressing Drug Shortage; Public Workshop, Request for Comments
1 of your filingslast filed Jan 27, 201217 co-filers
FDANonrulemakingFDA-2011-D-0771
Draft Blueprint for Prescriber Education for Long-Acting/Extended-Release Opioid Class-Wide Risk Evaluation and Mitigation Strategy; Availability; Request for Comments
1 of your filingslast filed Dec 14, 201115 co-filers
FDANonrulemakingFDA-2010-N-0633
Determination of System Attributes for the Tracking and Tracing of Prescription Drugs; Public Workshop
1 of your filingslast filed Jun 30, 201115 co-filers
FDANonrulemakingFDA-2010-N-0437
Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing
1 of your filingslast filed Nov 10, 20107 co-filers
FDANonrulemakingFDA-2009-N-0295
Providing Effective Information to Consumers about Prescription Drug Risks and Benefits; Public Workshop
1 of your filingslast filed Nov 30, 200910 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
1 of your filingslast filed Oct 21, 200971 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 Oct 13, 200918 co-filers
FDANonrulemakingFDA-2009-N-0294
Regulation of Tobacco Products; Request for Comments
1 of your filingslast filed Sep 30, 200980 co-filers
FDANonrulemakingFDA-2009-N-0143
Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs
1 of your filingslast filed Jun 17, 200947 co-filers
FDANonrulemakingFDA-2009-D-0001
Draft Guidance for Industry on Standards for Securing the Drug Supply Chain -- Standardized Numerical Identification for Prescription Drug Packages; Availability
1 of your filingslast filed Apr 17, 200917 co-filers
FDANonrulemakingFDA-2008-N-0038
Advisory Committee and Public Workshop Notices
1 of your filingslast filed Apr 1, 20098 co-filers
FDANonrulemakingFDA-2007-N-0214
Prescription Drug User Fee Act (PDUFA): Public Meeting
1 of your filingslast filed Jan 9, 200913 co-filers
FDANonrulemakingFDA-2008-P-0380
Requesting FDA Action on a "One Document Solution" for all Pharmacy-Based Communications - CLOSED
1 of your filingslast filed Jan 6, 20090 co-filers
FDANonrulemakingFDA-2007-N-0199
Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
1 of your filingslast filed Dec 4, 200813 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-0515
Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling
1 of your filingslast filed Aug 28, 200819 co-filers
FDANonrulemakingFDA-2007-N-0313
Maximizing the Public Health Benefit of Adverse Event Collection Throughout a Products Marketed Life Cycle; Public Workshop
1 of your filingslast filed Aug 14, 20081 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
FDANonrulemakingFDA-2008-N-0257
Draft Prescription Drug User Fee Act IV Drug Safety Five-Year Plan; Availability for Comment
1 of your filingslast filed Jul 3, 20082 co-filers
FDANonrulemakingFDA-2008-N-0120
Standards for Standardized Numerical Identifier, Track and Trace, and Authentication for Prescription Drugs
1 of your filingslast filed May 21, 200825 co-filers
FDANonrulemakingFDA-2008-N-0121
Technologies for Prescription Drug Identification, Track and Trace, or Authentication; Request for Information
1 of your filingslast filed May 21, 200823 co-filers
FDANonrulemakingFDA-2008-N-0162
Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Product Labeling: Medication Guide Requirements
1 of your filingslast filed May 20, 20082 co-filers
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