Resources

• PDA Comments to FDA Media Fills for PET Drugs
  PDA is pleased to offer comments on the FDA draft Guidance “Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs”; released for consultation September 30, 2011.
• PDA Comments EC-GDP Dec 31 2011
  PDA is pleased to provide comments on the EU Commission Guidelines on “Good Distribution Practice of Medicinal Products for Human Use,” released for consultation, July 15, 2011.
• QRA Regulatory Submissions ICHQ11
  PDA is pleased to offer comments on the ICH draft Guidance in the matter of “Q11 Development and Manufacture of Drug Substances, released for consultation on June 29, 2011.
• PDA Comments EMA-BWP Biotech PV 31 Aug 2011
  PDA is pleased to provide comments on the concept paper proposing a guideline on process validation for protein biotech medicinal products; released for consultation on May 19, 2011.
• QRA RAQAB FDA Reg Submissions Biologics Sterility Testing
  PDA is pleased to support FDA’s Amendments to Sterility Test Requirements for Biologic Products, released for consultation June 21, 2011.
• PDA Comments EMA-BWP Biotech PV 31 Aug 2011
  PDA is pleased to provide comments on the concept paper proposing a guideline on process validation for protein biotech medicinal products; released for consultation on May 19, 2011
• FDA Docket FDA-2011-N-0259, Periodic Review of Existing Regulations; Retrospective Review under E.O. 13563
  PDA is pleased to offer comments on the Period Review of Existing Regulations; Retrospective Review under E.O. 13563
• PDA Comments on the Proposed Revision to Chapter 5 of the EU GMP Guide on Production
  PDA is pleased to provide comments on the proposed revision of Chapter 5 of the EU GMP Guide: Production, released for consultation in November 2010.
• PDA Comments on the Revised Chapter 7 of the EU GMP Guide on Outsourced Activities
  PDA is pleased to provide comments on the proposed revision of Chapter 7 of the EU GMP Guide: Outsourced Activities, released for consultation in November 2010.