2015 PDA Regulatory Comments

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Parenteral Drug Association Connecting People, Science and Regulation ^®

GMP for Advanced Therapy Medicinal Products 12 Nov 2015

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FDA Guidance for Industry Request for Quality Metrics 12 Nov 2015

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EDQM Biological Indicators and Related Microbial Preparations 25 Sep 2015

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FDA Draft Guidance for Industry Established Conditions 20 Aug 2015

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FDA Guidance for Industry Mixing Diluting or Repackaging Biological Products 20 May 2015

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WHO Proposal for Revision of Good Trade and Distribution Practices for Pharmaceutical Starting Materials 12 May 2015

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FDA Guidance for Industry Good Manufacturing Practices for Combination Products 27 Apr 2015

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FDA Draft Guidance for Industry Investigating and Reporting Adverse Reactions 21 April 2015

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WHO Good Pharmacopoeial Practices QAS13.526 30 Mar 2015

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FDA Draft Guidance for Human Cells Tissues and Cellular and Tissue-Based Products from Adipose Tissue 23 Feb 2015

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FDA Draft Guidance for Minimal Manipulation of Human Cells Tissues and Cellular and Tissue-Based Products 23 Feb 2015

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EC Annex 17 Real Time Release 17 Dec 2015

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