Science and Regulatory Affairs
2007 PDA Regulatory Comments
Resources
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PDA Comments on Guideline on Production and Quality Control of Monoclonal Antibodies and Related Substances - PDA Comments on ICHQ10 Pharmaceutical Quality Systems
Cover Letter to the FDA, October 9, 2007 - PDA Comments on ICH10: Pharmaceutical Quality System Comment Table, October 2007
- PDA Comments on Revisions to Canadian GMPs1
Proposal Letter to HPFD from PDA - PDA Comments on Revisions to Canadian GMPs2
PDA Recommendation and Rational Regarding the Proposal for Revisions to Canadian GMPs - PDA comments on the EMEA's draft content of the Batch Release certificate referred to in Art. 13.3 of Directive 2001/20/EC
- PDA Comments on the Proposed Revision to Chapter 1 of the GMP Guide to Include Reference to Quality Risk Management (QRM) Principles