2011 PDA Regulatory Comments

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Parenteral Drug Association Connecting People, Science and Regulation ^®

FDA Amendments to Sterility Test Requirements for Biologic Products 16 Sep 2011

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FDA Draft Guidance on ICHQ11 Development and Manufacture of Drug Substances 1 Sep 2011

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FDA Periodic Review of Existing Regulations under E.O. <13563> 27 Jun 2011

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EU GMP Guide Revision of on Production 28 Feb 2011

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EU GMP Guide Revision of Chapter <7> on Outsourced Activities 28 Feb 2011

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FDA Draft Guidance on Media Fills for Validation of Aseptic Preparations for PET Drugs 23 Dec 2011

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EMA Draft Guidance on Good Distribution Practice of Medicinal Products for Human Use 31 Dec 2011

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EMA-BWP Draft Guidance on Process Validation for Protein Biotech Medicinal Products 31 Aug 2011

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