Resources

• PDA Comments on WHO Good Practices for Pharmaceutical Microbiology Laboratories
  PDA is pleased to submit comments on the draft "WHO Good Practices for Pharmaceutical Microbiology Laboratories" (July 2010).
• PDA Comments on CMC Postapproval Manufacturing Changes Reportable in Annual Reports
  PDA is pleased to submit comments on the Draft Guidance for Industry in the matter of CMC Postapproval Manufacturing Changes Reportable in Annual Reports, Docket No. FDA-2010-D-0283.
• PDA Comments on the Guidelines on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials
  PDA is pleased to provide comments on the draft CMC guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials.
• 2010: PDA Comments on EU GMP Annex 2: Manufacture of Biological Medicinal Substances and Products for Human Use
  PDA is pleased to provide comments on the latest revision of the EU GMP Annex 2.
• 2010: PDA Comments to the EU Guidelines to GMP, Part 1, Medicinal Products for Human and Veterinary Use, Chapter 2, Personnel
  PDA is pleased to provide comments on the revised Chapter 2 of the EU GMP, originating November 18, 2009.
• 2010: PDA Comments to the EU Guidelines to GMP Part I, Medicinal Products for Human and Veterinary Use, Chapter 1, Quality Management System
  PDA is pleased to provide comments on the revised Chapter 1 of the EU GMP, originating from November 18, 2009.
• PDA Responds to FDA's Request for Comments on the Transparency Task Force
  PDA is pleased to respond to the FDA's request for comments on the Transparency Task Force.
• 2010: PDA Comments on "Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File and Content of a Site Master File
  PDA is pleased to offer comments on the Note for Guidance on Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File and Content of a Site Master File, ENTR/F2/MT/AM/JR d (2009), 10 December 2009
• 2010: PDA Comments on Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products
  PDA is pleased to offer comments on the draft Guidance for Industry, "Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products."
• 2010: PDA Comments on Current Good Manufacturing Practice Requirements for Combination Products
  PDA is pleased to offer comments on the prposed rule under 21 CFR Part 4, Docket No. FDA-2009-N-0435-0004 in the matter of "Current Good Manufacturing Requirements for Combination Products, f/k/a Docket No. FDA-2008-D-0409.
• PDA Comments on Postmarketing Safety Reporting for Combination Products / FDA-2008-N-0424
  PDA is pleased to offer comments on the proposed rule under 21 CFR Part 4, "Postmarketing Safety Reporting for Combination Products."