PDA Regulatory Commenting
Each PDA Technical Advisory Board:
- identifies current regulatory and quality issues affecting the development, manufacturing and quality of healthcare products,
- advises PDA on the impact of such issues,
- recommends a plan of action for PDA response, and
- develops and makes recommendations to the PDA Board of Directors on association positions.
These issues may include proposed regulations, technical guidance documents, inspection procedures, policy statements, Pharmacopoeia proposals, standards setting activities, and other related items developed by the global regulatory bodies (e.g. US FDA,EMA, WHO, USP, ANVISA).
For more information or to suggest a topic for PDA commenting, please contact Carrie Horton, Program Manager of Regulatory Affairs, horton@pda.org.
Comments Archive
2024 PDA Regulatory Comments
- PDA Comments to Chinese Pharmacopeial Chapter 9653 Guidelines for Microbial Testing of Pharmaceutical Packaging Material 20 March 2024 (502 KB)
- PDA Comments to USP Microbiology Expert Committee on Bioburden Test 1119.1 9 April 2024 (376 KB)
- PDA Comments to USP Microbiology Expert Committee on Bioburden Monitoring 1119 9 April 2024 (457 KB)
- PDA Comments to FDA Docket 2023-N-5653 for FDA Draft Report and Plan on the Best Practices for Guidance 4 March 2024 (276 KB)
- PDA Comment to FDA Docket 2023-D-4395 Use of Real-World Evidence to Support Regulatory Decision Making for Medical Devices 7 February 2024 (431 KB)
2023 PDA Regulatory Comments
- PDA Comments to EMA Reflection Paper on the Use of Artificial Intelligence in the Lifecycles of Medicines December 2023 (401 KB)
- PDA Comments to FDA Docket 2023-N-3721 Quality Management Maturity Program for Drug Manufacturing Establishments December 2023 (339 KB)
- PDA Comments to FDA Docket 2023-D-3031 Alternative Tools Assessing Drug Manufacturing Facilities Identified in Pending Applications Draft Guidance for Industry - November 2023 (326 KB)
- PDA Comments to FDA Docket 2023-N-3742 Scientific Challenges and Opportunities to Advance the Development of Individualized Cellular and Gene Therapies November 2023 (303 KB)
- PDA Comments to EMA Concept Paper on the Development of a Guideline on the 4 Quality Aspects of mRNA Vaccines September 2023 (302 KB)
- PDA Comments to FDA Docket 2023-N-0743 Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products August 2023 (337 KB)
- PDA Comments to FDA Docket 2023-N-1585 Identification, Assessment and Control of Nitrosamine Drug Substance-Related Impurities in Human Drug Products - July 2023 (314 KB)
- PDA Comments to FDA Docket 2023-N-0487 for Artificial Intelligence in Drug Manufacturing Notice-Request for Information and Comments April 2023 (283 KB)
2022 PDA Regulatory Comments
- FDA Docket No 2020-D-1136-0057 Guidance for Industry Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Feb 2022 (354 KB)
- PDA comments to FDA Docket 2022-D-0705-0001 July 2022 (214 KB)
- PDA Comments to EMA ICH Quality Risk Management Q1 R1 March 2022 (225 KB)
- PDA Comments to FDA Docket 2022-D-0810 Remote Regulatory Assessments Sept 2022 (284 KB)
- PDA Comments FDA Docket No FDA 2021 D 0241 0002 Inspection of Injectable Products for Visible Particulates Guidance for Industry Feb 2022 (312 KB)
- PDA Comments to FDA Docket 2022-N-1777 Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting (176 KB)
- PDA_Comments_on_USP_Stimuli_Article-Sterility_by_Design_for_Sterile_Products (329 KB)
- PDA Comments to FDA Docket 2022-N-0075 Quality Metrics Reporting Program June 2022 (438 KB)
2021 PDA Regulatory Comments
- PDA Comments to EMA Guideline on Computerised Systems and Electronic Data in Clinical Trials December 2021 (293 KB)
- PDA Comments to Health Canada Issue Identification Paper - Drug-Device Combination Products 21 July 2021 (255 KB)
- PDA Comments to USP Stimuli to the Revision Process Filling the Pharmacopeial Gaps of Visual Inspection 26 July 2021 (170 KB)
- PDA Comments to FDA Docket No 2021-D-1031 Draft Guidance for Industry - Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act Dec 2021 (135 KB)
- PDA Comments to FDA Guidance on Manufacturing Considerations for Licensed and Investigational Cell & Gene Therapy Products 30 April 2021 (76 KB)
- PDA Comments to WHO Guidelines on the Transfer of Technology in Pharmaceutical Manufacturing rev 1.1 June 2021 (362 KB)
- PDA Comments to WHO Guidelines on the Transfer of Technology in Pharmaceutical Manufacturing 19 Feb 2021 (419 KB)
- PDA Comments on USP General Chapter 1042 Cell Banking for Recombinant Biologic 31 Mar 2021 (220 KB)
- PDA Comments to Health Canada Guidance Process Validation - Terminal Sterilization Processes for Drugs 16 June 2021 (462 KB)
- PDA Comments to USP Chapters 1229_19 and 1229_20 Sterilization and Decontamination Nov 2021 (290 KB)
- PDA Comments to FDA Guidance on Development and Licensure of Vaccines to Prevent Covid-19 21 Jan 2021 (141 KB)
- PDA Commentsr to FDA Docket No 2021 D 0432 Microbiological Quality Considerations in Non Sterile Drug Manufacturing Dec 2021 (364 KB)
- PDA Comments to USP Rules & Procedures of the Council of Experts 2020-2025 8 Jan 2021 (157 KB)
2020 PDA Regulatory Comments
- PDA Comment to FDA Guidance on Identification of Manufacturing Establishments in Applications 9 Oct 2020 (274 KB)
- PDA Comments to EMA Annex 1 Revision - Manufacture of Sterile Medicinal Products 13 Jul 2020 (341 KB)
- PDA Comments to USP General Notices Revision (Biologics Nomenclature) 31 Jul 2020 (60 KB)
- PDA Comments to FDA Guidance on Planning for the Effects of High Absenteeism 29 May 2020 (72 KB)
- PDA Comments to WHO Working Document QAS-20.849 on Cleaning Validation 30 Jun 2020 (185 KB)
- PDA Comments to EDQM Chapter 5.26 Implementation of Pharmacopoeial Procedures 31 Dec 2020 (145 KB)
- 2020-11-24 USP1085.1 Use of Recombinant Reagents in BET_PDA Comments (186 KB)
- PDA Comments to USP General Notices Revision 31 Mar 2020 (149 KB)
- PDA Comments to WHO Guideline on Data Integrity 15 Jan 2020 (83 KB)
2019 PDA Regulatory Comments
- PDA Response to EMA Guideline on Quality Requirements for Drug Device Combinations 31 Aug 2019 (252 KB)
- PDA Response to WHO Draft Guidance on Production of Water For Injection By Means Other Than Distillation 20 Sep 2019 (232 KB)
- PDA Response to PICS Draft Guidance on Good Practices for Data Management and Integrity 28 Feb 2019 (178 KB)
- PDA Response to FDA Guidance on Voluntary Recalls 24 Jun 2019 (242 KB)
- PDA Response to FDA CDER Program for Recognition Voluntary Consensus Standards 13 Apr 2019 (217 KB)
- PDA Response to USP General Chapter Proposals on Distribution and Mean Kinetic Temperature 4 Dec 2019 (361 KB)
- PDA Response to FDA Quality Metrics and Quality Culture Initiatives 10 Oct 2019 (137 KB)
- PDA Response to USP 2020 Convention Resolution Request 27 Aug 2019 (203 KB)
- PDA Response to Health Canada Draft Guidance on GMPs for APIs 29 Mar 2019 (219 KB)
- PDA Response to WHO Draft Guidance on Production of WFI by Means Other Than Distillation 15 Apr 2019 (254 KB)
- PDA Response to Health Canada Guidelines for Environmental Control During Storage and Transportation 20 Mar 2019 (192 KB)
- PDA Response to EDQM Pharmacopeia Chapter 2.6.32. Test for Bacterial Endotoxins Using Recombinanat Factor C 29 Mar 2019 (674 KB)
2018 PDA Regulatory Comments
- PDA Response to EDQM Revision of EP 5.1.5 Application of F Concepts to Heat Sterilisation 28 Dec 2018 (348 KB)
- PDA Response to FDA Draft Guidance on CMCs for Gene Therapy INDs 6 Dec 2018 (277 KB)
- PDA Response to FDA Draft Guidance on Testing Gene Therapy Products for RCR 6 Dec 2018 (87 KB)
- PDA Response to Israel MOH Draft QP SOP 1 Mar 2018 (191 KB)
- PDA Response to ANVISA Stability Revised Guidance 5 Apr 2018 (394 KB)
- PDA Response to Annex 1 Revision: Manufacture of Sterile Medicinal Products 20 Mar 2018 (577 KB)
- PDA Response to FDA Request for Regulation and Paperwork Reduction 13 Apr 2018 (195 KB)
- PDA Response to FDA CMC Changes for Certain Biological Products 22 Mar 2018 (204 KB)
- PDA Response to EMA EU Template for GMP Non-Compliance Statement 15 May 2018 (99 KB)
- PDA Response to ICH Q12 Health Canada 10 Aug 2018 (367 KB)
- PDA Response to EDQM Proposed EP 5.17.2. Recommendations on Testing of Particulate Contamination 28 Dec 2018 (363 KB)
- PDA Response to USP Changes to COE Rules 7 Jan 2018 (150 KB)
- PDA Response to EMA QP and API Site Audit Questions 2 May 2018 (126 KB)
2017 PDA Regulatory Comments
- PDA Response to FDA Draft Guidance on Comparative HF Studies Drug Device Combo Products for ANDA 31 Mar 2017 (218 KB)
- PDA Response to FDA Interchangeability Draft Guidance on Human Factors 20 Jun 2017 (143 KB)
- PDA Response to FDA Revised Draft Guidance on Quality Metrics 27 Mar 2017 (235 KB)
- PDA Response to WHO Draft Guidlines on Procedures and Data Requirement for PAC Biotherapeutics 15 Sep 2017 (208 KB)
- PDA Response to CFDA Draft Guidance on Drug Data Management 9 Mar 2017 (130 KB)
- PDA Response to EMA Concept Paper on Need for Revision of Note for Guideline on Water for Pharmaceutical Use 6 Jun 2017 (108 KB)
- PDA Response to CFDA Draft Guidance on Simulation Testing of Sterile Processes 7 Sep 2017 (330 KB)
- PDA Response to EMA Q and A for Shared Facilities and HBEL Limits 30 May 2017 (472 KB)
- PDA Response to Health Canada Draft Guidance on GMPs for Drug Products 1 May 2017 (229 KB)
2016 PDA Regulatory Comments
- FDA Draft Guidance for Industry - Human Factors Studies and Related Clinical Study Considerations 4 May 2016 (276 KB)
- FDA Draft AMD for Immunogenicity Testing 6 Jul 2016 (154 KB)
- PDA Response MHRA Data Integrity GxP Guideline 1 Nov 2016 (195 KB)
- USP General Chapters Prospectus 29 Mar 2016 (151 KB)
- WHO Draft Guideline QAS 16.666 Validation 18 Jul 2016 (124 KB)
- FDA eCTD Conformance Guide - Considerations for Combination Product 19 Jan 2016 (346 KB)
- WHO Guidelines on Validation 23 Aug 2016 (158 KB)
- EMA Draft Guideline on Manufacture of the Finished Dosage Form 15 Jan 2016 (263 KB)
- EMA Sterilization Guidance 13 Oct 2016 (535 KB)
- FDA Draft Guidance Comparability Protocols 30 Jun 2016 (153 KB)
- FDA Metrics Technical Conformance Guide 26 Sep 2016 (146 KB)
- WHO Draft Guideline QAS 16.671 Appendix 4 Analytical Method Validation 23 Aug 2016 (149 KB)
- FDA Draft Guidance Insanitary Conditions at Compounding Facilities 3 Oct 2016 (159 KB)
- PDA Response to WHO PAC for Biotherapeutic Products 19 Dec 2016 (210 KB)
- FDA Draft Guidance Implementation of Deemed to be a License Provision of BPCIA 23 May 2016 (198 KB)
- EMA QA Production of WFI by Non Distillation Methods 4 Nov 2016 (219 KB)
- FDA Draft Guidance Data Integrity and Compliance with cGMP 19 Jun 2016 (184 KB)
2015 PDA Regulatory Comments
- WHO Good Pharmacopoeial Practices QAS13.526 30 Mar 2015 (712 KB)
- EC Annex 17 Real Time Release 17 Dec 2015 (271 KB)
- GMP for Advanced Therapy Medicinal Products 12 Nov 2015 (345 KB)
- FDA Draft Guidance for Human Cells Tissues and Cellular and Tissue-Based Products from Adipose Tissue 23 Feb 2015 (424 KB)
- FDA Draft Guidance for Minimal Manipulation of Human Cells Tissues and Cellular and Tissue-Based Products 23 Feb 2015 (411 KB)
- FDA Guidance for Industry Mixing Diluting or Repackaging Biological Products 20 May 2015 (663 KB)
- FDA Guidance for Industry Good Manufacturing Practices for Combination Products 27 Apr 2015 (654 KB)
- FDA Draft Guidance for Industry Investigating and Reporting Adverse Reactions 21 April 2015 (582 KB)
- FDA Guidance for Industry Request for Quality Metrics 12 Nov 2015 (486 KB)
- WHO Proposal for Revision of Good Trade and Distribution Practices for Pharmaceutical Starting Materials 12 May 2015 (623 KB)
- FDA Draft Guidance for Industry Established Conditions 20 Aug 2015 (805 KB)
- EDQM Biological Indicators and Related Microbial Preparations 25 Sep 2015 (624 KB)
2014 PDA Regulatory Comments
- FDA Draft Guidance for Industry Analytical Procedures and Methods Validation 20 May 2014 (206 KB)
- EU GMP Annex 15 Qualification and Validation 29 May 2014 (188 KB)
- EU Good Distribution Practice of Medicinal Products for Human Use 17 Jul 2014 (109 KB)
- FDA Draft Guidance for Industry cGMP Interim Guidance for Human Drug Compounding Outsourcing Facilities 28 Aug 2014 (420 KB)
- FDA Draft Guidance for Industry cGMP Interim Guidance for Human Drug Compounding Outsourcing Facilities 28 Aug 2014 (420 KB)
- CFDA Draft Guidance GMPs Draft Annex 1 Qualification and Validation 24 Nov 2014 (895 KB)
- EMA Guideline on Process Validation of Biotechnology-Derived Active Substances 28 Oct 2014 (469 KB)
- Health Canada Quality Draft Guidance on New Drug and Abbreviated New Drug Submissions 9 Apr 2014 (234 KB)
2013 PDA Regulatory Comments
- FDA Draft Guidance on Glass Syringes for Delivering Drug and Biological Products 2 Jul 2013 (198 KB)
- EU Commission Draft Guidance on Use of Porcine Trypsin Used in Manufacture of Human Biological Medicinal Products 8 Oct 2013 (205 KB)
- WHO Draft Guidance on GMP for Pharmaceutical Products 28 Mar 2013 (192 KB)
- EU Commission Draft Template on GMPCompliance of Investigational Medicinal Products Manufactured in Non-EU Countries 2 Apr 2013 (288 KB)
- EU Commission Draft Guidance on Principles of Good Distribution Practices for Active Substances for Medicinal Products for Human Use 30 Apr 2013 (164 KB)
- EU Commission Draft Guidance on GMP for Excipients of Medicinal Products for Human Use 30 Apr 2013 (158 KB)
- FDA Draft Guidance on Delaying Denying Limiting or Refusing a Drug Inspection 13 Sep 2013 (166 KB)
- FDA Draft Guidance on Contract Manufacturing Arrangements for Drugs 29 Jul 2013 (171 KB)
- EU Commission Draft Guidance on Setting Health Based Exposure Limits for Use 26 Jun 2013 (184 KB)
- EU Commission Draft Guidance on Similar Biological Medicinal Products 30 Oct 2013 (175 KB)
- FDA Proposed Rule on Administrative Detention of Drugs 13 Sep 2013 (162 KB)
- USP Proposed In-Process Revision to General Notice Section 5 Monograph Components 26 Mar 2013 (141 KB)
- FDA Draft Guidance on Drug Shortages Strategic Plan 13 Mar 2013 (180 KB)
2012 PDA Regulatory Comments
- FDA Draft Guidance on Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product 13 Apr 2012 (103 KB)
- FDA Draft Guidance on Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product 13 Apr 2012 (116 KB)
- FDA Draft Guidance on Scientific Considerations in Demonstrating Biosimilarity to a Reference Product 13 April 2012 (102 KB)
- EU Commission Draft Guidance on GMP for Active Substances in Medicinal Products for Human Use 20 Apr 2012 (223 KB)
- EMA Draft Guidance on Process Validation 30 Oct 2012 (927 KB)
2011 PDA Regulatory Comments
- FDA Amendments to Sterility Test Requirements for Biologic Products 16 Sep 2011 (103 KB)
- FDA Draft Guidance on Media Fills for Validation of Aseptic Preparations for PET Drugs 23 Dec 2011 (125 KB)
- FDA Draft Guidance on ICHQ11 Development and Manufacture of Drug Substances 1 Sep 2011 (148 KB)
- EMA Draft Guidance on Good Distribution Practice of Medicinal Products for Human Use 31 Dec 2011 (352 KB)
- EMA-BWP Draft Guidance on Process Validation for Protein Biotech Medicinal Products 31 Aug 2011 (110 KB)
2010 PDA Regulatory Comments
- EMA Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File and Content of a Site Master File 30 Mar 2010 (656 KB)
- FDA CMC Draft Guidance Postapproval Manufacturing Changes Reportable in Annual Reports 23 Sep 2010 (54 KB)
- WHO Good Practices for Pharmaceutical Microbiology Laboratories 30 Sep 2010 (234 KB)
- FDA DDM Rule on Current GMP Requirements for Combination Products 4 Feb 2010 (61 KB)
- FDA DDM Draft Guidance on Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products 4 Mar 2010 (74 KB)
- FDA DDM Request for Comments on the Transparency Task Force 12 Apr 2010 (34 KB)
- EMA CMC Draft Guidelines on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials 31 Aug 2010 (252 KB)
- FDA Draft Rule on Postmarketing Safety Reporting for Combination Products 27 Jan 2010 (44 KB)
2009 PDA Regulatory Comments
- 2009 PDA Comments to Concept Paper on the Revision of the EU Guideline on GDP (136 KB)
- 2009 PDA Comments on Draft Guidance on Potency Testing of Cellular and Gene Therapy Products (136 KB)
- 2009 PDA Comments on Securing the Drug Supply Chain (36 KB)
- 2009 PDA Comments on EU Guidelines to GMP Draft Annex 13 (131 KB)
- 2009 PDA Comments to EDQM Pharmaeuropa Chapter XXXX2031 (241 KB)
- 2009 FDA Comments on Federal Docket Management System Docket FDA-2009-D-0179 (63 KB)
- 2009 PDA Comments on the Process Validation Guidance (411 KB)
- 2009 PDA Comments on the Concept Paper for Implementation of ICHQ10 (136 KB)
- 2009 PDA Comments to EDQM on Pharmaeuropa Chapters 2-6-16 and 5-2-3 (124 KB)
- 2009 PDA Comments on Recommendations for the Evaluation of Animal Cell Cultures as Substrates for the Manufacture of Biological Medicinal Products and for the Characterization of Cell Banks (225 KB)
- 2009 PDA Comments on the Revised TSE Note for Guidance (335 KB)
2008 PDA Regulatory Comments
- 2008 PDA Comments on Proposed Changes to Drug Product GMPs for Finished Pharmaceuticals (65 KB)
- 2008 PDA Comments on EU Guidelines to GMP Chapter 4 (40 KB)
- 2008 PDA Comments on ICH Draft Guidance on Q4B (42 KB)
- 2008 PDA Comments on EU Guidelines to GMP Draft Annex 11 Computerised Systems (89 KB)
- 2008 PDA Comments on Draft Guidance for Parametric Release (85 KB)
- 2008 PDA Comments on GMP Draft Annex 2 (106 KB)
- 2008 PDA Comments on ICH Q8 (279 KB)
2007 PDA Regulatory Comments
- PDA Comments on ICH10 Pharmaceutical Quality System Comment Table October 2007 (27 KB)
- PDA Comments on ICHQ10 Pharmaceutical Quality Systems (36 KB)
- PDA Comments on Guideline on Production and Quality Control of Monoclonal Antibodies and Related Substances (124 KB)
- PDA Comments on Revisions to Canadian GMPs1 (37 KB)
- PDA Comments on the Proposed Revision to Chapter 1 of the GMP Guide to Include Reference to Quality Risk Management -QRM- Principles (74 KB)
- PDA Comments on Revisions to Canadian GMPs2 (17 KB)
- PDA comments on the EMEAs draft content of the Batch Release certificate referred to in Art-13-3 of Directive 2001-20-EC (73 KB)
2006 PDA Regulatory Comments
- Direct Final and Proposed Rules Current Good Manufacturing Practice Regulation and Investigational New Drugs (177 KB)
- PDA Comments on Draft FDA Guidance for Industry - Phase I GMPs (40 KB)
- Draft Guidance for Industry INDs - Approaches to Complying with CGMP During Phase I Docket No 2005D-0286 (185 KB)
- PDA Comments on Virus Safety Evaluation of Biotechnological Investigational Medicinal Products Guidance1 (47 KB)
- PDA Comments on Biological Starting Materials Guidance1 (37 KB)
- PDA Comments on GMP Annex 1-1 (47 KB)
- PDA Comments on GMP Annex 1-2 (87 KB)
- PDA Comments on Biological Starting Materials Guidance2 (142 KB)
- PDA Comments on GMP Annex 1-3 (77 KB)
- PDA Comments on Virus Safety Evaluation of Biotechnological Investigational Medicinal Products Guidance2 (79 KB)
- 2006 FDA Cover Letter Direct and Final Rule (177 KB)
- Annex 1 Comment Submission Document to the EMEA (87 KB)
2005 PDA Regulatory Comments
- PDA Comments on ICH Q9-2 (44 KB)
- PDA Comments on ICH Q9-1 (92 KB)
- ICH Q8 (303 KB)
- PDA Comments on the Proposed Changes to USP General Chapter 1 Injections (40 KB)