2014 PDA Regulatory Comments

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Parenteral Drug Association Connecting People, Science and Regulation ^®

FDA Draft Guidance for Industry cGMP Interim Guidance for Human Drug Compounding Outsourcing Facilities 28 Aug 2014

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EMA Guideline on Process Validation of Biotechnology-Derived Active Substances 28 Oct 2014

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CFDA Draft Guidance GMPs Draft Annex 1 Qualification and Validation 24 Nov 2014

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FDA Draft Guidance for Industry cGMP Interim Guidance for Human Drug Compounding Outsourcing Facilities 28 Aug 2014

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EU Good Distribution Practice of Medicinal Products for Human Use 17 Jul 2014

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Health Canada Quality Draft Guidance on New Drug and Abbreviated New Drug Submissions 9 Apr 2014

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EU GMP Annex 15 Qualification and Validation 29 May 2014

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FDA Draft Guidance for Industry Analytical Procedures and Methods Validation 20 May 2014

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