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2010 PDA Regulatory Comments
PDA Responds to FDAs 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.
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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).
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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.
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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."
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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.
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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PDA is pleased to submit comments on the Draft Guidance for Industry in the matter of CMC Postapproval Manufacturing Changes Reportable in Annual Reports, Docket No. FDA-2010-D-0283.
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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
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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PDA is pleased to offer comments on the draft Guidance for Industry, "Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products."
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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.
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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.
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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.
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