2019 PDA Regulatory Comments

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Parenteral Drug Association Connecting People, Science and Regulation ^®

PDA Response to USP General Chapter Proposals on Distribution and Mean Kinetic Temperature 4 Dec 2019

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PDA Response to FDA Quality Metrics and Quality Culture Initiatives 10 Oct 2019

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PDA Response to WHO Draft Guidance on Production of Water For Injection By Means Other Than Distillation 20 Sep 2019

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PDA Response to EMA Guideline on Quality Requirements for Drug Device Combinations 31 Aug 2019

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PDA Response to USP 2020 Convention Resolution Request 27 Aug 2019

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PDA Response to FDA Guidance on Voluntary Recalls 24 Jun 2019

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PDA Response to USP General Chapter <1235> Vaccines for Human Use – General Considerations 31 May 2019

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PDA Response to USP General Chapter <11> Reference Standards 31 May 2019

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PDA Response to WHO Draft Guidance on Production of WFI by Means Other Than Distillation 15 Apr 2019

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PDA Response to EDQM Pharmacopeia Chapter 2.6.32. Test for Bacterial Endotoxins Using Recombinanat Factor C 29 Mar 2019

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PDA Response to FDA CDER Program for Recognition Voluntary Consensus Standards 13 Apr 2019

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PDA Response to Health Canada Draft Guidance on GMPs for APIs 29 Mar 2019

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PDA Response to Health Canada Guidelines for Environmental Control During Storage and Transportation 20 Mar 2019

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PDA Response to PICS Draft Guidance on Good Practices for Data Management and Integrity 28 Feb 2019

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