Which federal agency does Parenteral Drug Association comment on most?

Parenteral Drug Association is most active at the Food and Drug Administration.

← OpenPolis Sign in

Parenteral Drug Association

Unclaimed

Industry

Pharmaceuticals

Staff

520

4350 East-West Hwy, Bethesda, Maryland

Phone

+1 301-656-5900

Website

pda.org

Engagement overview

Parenteral Drug Association has filed 94 public comments across 82 dockets at 2 federal agencies, most actively at the Food and Drug Administration.

Comments filed

Dockets engaged

Agencies

Jul 15, 2026

Last filing

Is this your organization?

Claim Parenteral Drug Association to unlock owner-only intelligence across your 82 dockets:

Coalition map — every organization that files alongside you
Ally & opposition tags on your co-filers
AI briefs on the rulemakings you engage
Deadline calendar & alerts for open comment windows

Claim this profile →or book a meetingFree · verify instantly with your work email.

Agency footprint

All agencies FDA81 CISA1

Dockets · FDA (81)

sorted by most recent filing

FDANonrulemakingFDA-2026-D-1255

Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry; Availability

1 of your filingslast filed Jul 15, 20266 co-filers

FDANonrulemakingFDA-2025-D-6130

Establishing Impurity Specifications for Antibiotics; Draft Guidance for Industry; Availability

1 of your filingslast filed Jun 24, 20261 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Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry; Availability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-2025-D-4678

Q3E Guideline for Extractables and Leachables; International Council for Harmonisation; Draft Guidance for Industry; Availability

1 of your filingslast filed Feb 3, 20261 co-filers

FDANonrulemakingFDA-2025-D-4051

Quality Management System Information for Certain Premarket Submission Reviews; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

1 of your filingslast filed Jan 21, 20260 co-filers

FDANonrulemakingFDA-2025-D-3049

Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products; Draft Guidance for Industry; Availability

1 of your filingslast filed Dec 18, 20250 co-filers

FDANonrulemakingFDA-2022-D-2301

Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations; Draft Guidance for Industry; Availability

1 of your filingslast filed Aug 28, 20250 co-filers

FDANonrulemakingFDA-2025-D-1106

Q1 Stability Testing of Drug Substances and Drug Products; International Council for Harmonisation; Draft Guidance for Industry; Availability

1 of your filingslast filed Aug 22, 20251 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 4, 202532 co-filers

FDANonrulemakingFDA-2024-D-5374

Considerations for Complying With 21 CFR 211.110; Draft Guidance for Industry; Availability

1 of your filingslast filed Apr 4, 20250 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 2, 20254 co-filers

FDANonrulemakingFDA-2024-N-4821

Best Practices for FDA Communication with Interested Parties

1 of your filingslast filed Feb 4, 20251 co-filers

FDANonrulemakingFDA-2024-N-3878

New Drugs Regulatory Program Modernization: Integrated Assessment of Marketing Applications and Integrated Review Documentation; Request for Comments

1 of your filingslast filed Dec 6, 20240 co-filers

FDANonrulemakingFDA-2024-D-2560

Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products; Draft Guidance for Industry; Availability

1 of your filingslast filed Oct 1, 20242 co-filers

FDANonrulemakingFDA-2024-D-1829

Platform Technology Designation Program; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request

1 of your filingslast filed Aug 28, 20241 co-filers

FDANonrulemakingFDA-2023-D-5021

Processes and Practices Applicable to Bioresearch Monitoring Inspections; Draft Guidance for Industry; Availability

1 of your filingslast filed Aug 6, 20241 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

FDANonrulemakingFDA-2023-D-4395

Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff; Availability

1 of your filingslast filed Feb 9, 20241 co-filers

FDANonrulemakingFDA-2023-D-4416

Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities; Draft Guidance for Industry; Availability

1 of your filingslast filed Dec 20, 20231 co-filers

FDANonrulemakingFDA-2023-N-3721

Quality Management Maturity Program for Drug Manufacturing Establishments; Establishment of a Public Docket; Request for Comments

1 of your filingslast filed Dec 15, 20231 co-filers

FDANonrulemakingFDA-2023-N-3742

Scientific Challenges and Opportunities to Advance the Development of Individualized Cellular and Gene Therapies; Request for Information

1 of your filingslast filed Nov 21, 20230 co-filers

FDANonrulemakingFDA-2023-D-3031

Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications; Draft Guidance for Industry; Availability

1 of your filingslast filed Nov 20, 20230 co-filers

FDANonrulemakingFDA-2023-N-0743

Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products; Availability

1 of your filingslast filed Aug 10, 20232 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-N-0487

Discussion Paper: Artificial Intelligence in Drug Manufacturing, Notice; request for information and comments.

1 of your filingslast filed Apr 28, 20232 co-filers

FDANonrulemakingFDA-2022-N-1777

Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

1 of your filingslast filed Oct 18, 20221 co-filers

FDANonrulemakingFDA-2022-D-0810

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

1 of your filingslast filed Sep 22, 20226 co-filers

FDANonrulemakingFDA-2022-D-0705

Q9(R1) Quality Risk Management; International Council for Harmonisation; Draft Guidance for Industry; Availability

1 of your filingslast filed Jul 13, 20220 co-filers

FDANonrulemakingFDA-2022-N-0075

FDA Quality Metrics Reporting Program; Establishment of a Public Docket; Request for Comments

1 of your filingslast filed Jun 9, 20221 co-filers

FDANonrulemakingFDA-2021-D-0241

Inspection of Injectable Products for Visible Particulates; Draft Guidance for Industry; Availability

1 of your filingslast filed Feb 17, 20220 co-filers

FDANonrulemakingFDA-2020-D-1136

Center for Drug Evaluation and Research (CDER): COVID-19

1 of your filingslast filed Feb 8, 20221 co-filers

FDANonrulemakingFDA-2021-D-0432

Microbiological Quality Considerations in Non-Sterile Drug Manufacturing; Draft Guidance for Industry; Availability

1 of your filingslast filed Dec 29, 20211 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 Dec 23, 20213 co-filers

FDANonrulemakingFDA-2020-D-1137

Center for Biologics Evaluation and Research (CBER): COVID-19

1 of your filingslast filed Jan 22, 20210 co-filers

FDANonrulemakingFDA-2020-D-1294

Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products; Draft Guidance for Industry; Availability

1 of your filingslast filed Oct 29, 20200 co-filers

FDANonrulemakingFDA-2017-D-6821

Providing Comments on CDER Level 2 Guidances

1 of your filingslast filed Oct 13, 20202 co-filers

FDANonrulemakingFDA-2009-D-0568

Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products

3 of your filingslast filed Jun 1, 20200 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-2018-D-4417

Center for Drug Evaluation and Research’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality; Draft Guidance for Industry; Availability

1 of your filingslast filed Apr 17, 20190 co-filers

FDANonrulemakingFDA-2008-D-0205

Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs); Availability

1 of your filingslast filed Dec 10, 20180 co-filers

FDANonrulemakingFDA-1999-D-0081

Testing for Replication Competent Retrovirus in Retroviral

1 of your filingslast filed Dec 7, 20180 co-filers

FDANonrulemakingFDA-2018-D-1609

Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management; International Council for Harmonisation; Final Guidance for Industry

1 of your filingslast filed Aug 16, 20180 co-filers

FDANonrulemakingFDA-2017-D-0154

Considerations in Demonstrating Interchangeability With a Reference Product

1 of your filingslast filed Jun 26, 20172 co-filers

FDANonrulemakingFDA-2016-D-4412

Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA; Draft Guidance for Industry; Availability

1 of your filingslast filed Apr 4, 20171 co-filers

FDANonrulemakingFDA-2015-D-2537

Request for Quality Metrics

2 of your filingslast filed Mar 28, 20172 co-filers

FDANonrulemakingFDA-2016-D-1594

Quality Metrics Technical Conformance Guide – Technical Specifications Document; Availability

1 of your filingslast filed Dec 9, 20160 co-filers

FDANonrulemakingFDA-2016-D-2268

Insanitary Conditions at Compounding Facilities

1 of your filingslast filed Oct 13, 201621 co-filers

FDANonrulemakingFDA-2009-D-0539

Assay Development for Immunogenicity Testing of Therapeutic Proteins

1 of your filingslast filed Jul 7, 20160 co-filers

FDANonrulemakingFDA-2016-D-0973

Comparability Protocols for Drugs and Biologics: Chemistry, Manufacturing, and Controls Information

1 of your filingslast filed Jul 7, 20160 co-filers

FDANonrulemakingFDA-2016-D-1113

Data Integrity and Compliance With CGMP

1 of your filingslast filed Jun 24, 20160 co-filers

FDANonrulemakingFDA-2015-D-4848

Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development

1 of your filingslast filed Jun 21, 20161 co-filers

FDANonrulemakingFDA-2015-D-4750

Implementation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009

1 of your filingslast filed Jun 2, 20161 co-filers

FDANonrulemakingFDA-2015-D-3390

Electronic Common Technical Document Technical Conformance Guide

1 of your filingslast filed Jan 19, 20160 co-filers

FDANonrulemakingFDA-2005-N-0170

Current Good Manufacturing Practice Regulation and Investigational New Drugs

2 of your filingslast filed Nov 19, 20150 co-filers

FDANonrulemakingFDA-2013-N-1429

Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act

1 of your filingslast filed Sep 11, 20150 co-filers

FDANonrulemakingFDA-2014-D-1525

Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application

1 of your filingslast filed May 26, 20152 co-filers

FDANonrulemakingFDA-2013-N-0124

Food and Drug Administration Drug Shortages Task Force and Strategic Plan; Request for Comments

1 of your filingslast filed Mar 3, 201537 co-filers

FDANonrulemakingFDA-2014-D-1856

Guidance for Industry; Human Cells, Tissues, and Cellular and Tissue-Based Products from Adipose Tissue: Regulatory Considerations

1 of your filingslast filed Feb 23, 20150 co-filers

FDANonrulemakingFDA-2014-D-1696

Guidance for Industry and Food and Drug Administration Staff Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products

1 of your filingslast filed Feb 23, 20150 co-filers

FDANonrulemakingFDA-2014-D-0103

Analytical Procedures and Methods Validation for Drugs and Biologics

1 of your filingslast filed Jun 18, 20140 co-filers

FDANonrulemakingFDA-2013-D-0558

Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements; Availability

1 of your filingslast filed Aug 8, 20131 co-filers

FDANonrulemakingFDA-2013-D-0362

Draft Guidance for Industry and FDA Staff - Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4; Availability

1 of your filingslast filed Aug 1, 20130 co-filers

FDANonrulemakingFDA-2011-D-0605

Scientific Considerations in Demonstrating Biosimilarity to a Reference Product

1 of your filingslast filed Apr 16, 20121 co-filers

FDANonrulemakingFDA-2011-D-0611

Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

1 of your filingslast filed Apr 16, 20122 co-filers

FDANonrulemakingFDA-2011-D-0602

Draft Guidance for Industry on Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product; Availability

1 of your filingslast filed Apr 16, 20120 co-filers

FDANonrulemakingFDA-2011-D-0691

Draft Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs; Availability

1 of your filingslast filed Jan 10, 20120 co-filers

FDANonrulemakingFDA-2011-N-0080

Amendments to Sterility Test Requirements for Biological Products

2 of your filingslast filed Oct 18, 20110 co-filers

FDANonrulemakingFDA-2011-D-0436

International Conference on Harmonisation; Draft Guidance on Q11 Development and Manufacture of Drug Substances; Availability

1 of your filingslast filed Oct 18, 20110 co-filers

FDANonrulemakingFDA-2011-N-0259

Periodic Review of Existing Regulations; Retrospective Review Under Executive Order 13563

2 of your filingslast filed Jul 8, 20114 co-filers

FDANonrulemakingFDA-2010-D-0283

Draft Guidance for Industry on CMC Postapproval Manufacturing Changes Reportable in Annual Reports; Availability

2 of your filingslast filed Nov 1, 20100 co-filers

FDANonrulemakingFDA-1997-N-0040

Current Good Manufacturing Practice Requirements for Combination Products-CLOSED

1 of your filingslast filed Feb 4, 20100 co-filers

FDANonrulemakingFDA-2009-D-0179

Guidance for Industry: Technical Considerations for PEN, JET, and Related Injectors Intended for use With Drugs and Biological Products; Availability

2 of your filingslast filed Aug 10, 20091 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 15, 200917 co-filers

FDANonrulemakingFDA-2006-D-0408

International Conference on Harmonisation; Draft Guidance on Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Availability

1 of your filingslast filed Mar 18, 20090 co-filers

FDANonrulemakingFDA-2008-D-0559

Guidance for Industry on Process Validation: General Principles and Practices

1 of your filingslast filed Mar 4, 20091 co-filers

FDANonrulemakingFDA-2008-D-0520

Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products

2 of your filingslast filed Jan 9, 20090 co-filers

FDANonrulemakingFDA-2008-D-0391

Draft Guidance for Industry on Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes; Availability

1 of your filingslast filed Oct 6, 20080 co-filers

FDARulemakingFDA-2007-0614

Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Companion Document to the Direct Final Rule

2 of your filingslast filed Feb 26, 20080 co-filers

Attribution is name-based and imperfect. Firmographic data is third-party sourced and shown for demonstration. regulations.gov data is public record.