2010 PDA Regulatory Comments

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Parenteral Drug Association Connecting People, Science and Regulation ^®

FDA DDM Request for Comments on the Transparency Task Force 12 Apr 2010

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WHO Good Practices for Pharmaceutical Microbiology Laboratories 30 Sep 2010

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EMA CMC Draft Guidelines on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials 31 Aug 2010

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FDA Draft Rule on Postmarketing Safety Reporting for Combination Products 27 Jan 2010

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EMA GMP Revision of Annex <2> 19 Jul 2010

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FDA CMC Draft Guidance Postapproval Manufacturing Changes Reportable in Annual Reports 23 Sep 2010

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EMA Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File and Content of a Site Master File 30 Mar 2010

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FDA DDM Draft Guidance on Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products 4 Mar 2010

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EMA GMP Draft Guidance on Chapter <1> Quality Management System 31 May 2010

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EMA GMP Draft Guidance on Chapter <2> Personnel 31 May 2010

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FDA DDM Rule on Current GMP Requirements for Combination Products 4 Feb 2010

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