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Parenteral Drug Association
Connecting People, Science and Regulation
®
Parenteral Drug Association
Connecting People, Science and Regulation
®
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2016 PDA Regulatory Comments
PDA Response to WHO PAC for Biotherapeutic Products 19 Dec 2016
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EMA QA Production of WFI by Non Distillation Methods 4 Nov 2016
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PDA Response MHRA Data Integrity GxP Guideline 1 Nov 2016
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EMA Sterilization Guidance 13 Oct 2016
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FDA Draft Guidance Insanitary Conditions at Compounding Facilities 3 Oct 2016
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FDA Metrics Technical Conformance Guide 26 Sep 2016
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WHO Draft Guideline QAS 16.671 Appendix 4 Analytical Method Validation 23 Aug 2016
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WHO Guidelines on Validation 23 Aug 2016
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WHO Draft Guideline QAS 16.666 Validation 18 Jul 2016
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FDA Draft AMD for Immunogenicity Testing 6 Jul 2016
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FDA Draft Guidance Comparability Protocols 30 Jun 2016
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FDA Draft Guidance Data Integrity and Compliance with cGMP 19 Jun 2016
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FDA Draft Guidance Implementation of Deemed to be a License Provision of BPCIA 23 May 2016
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FDA Draft Guidance for Industry - Human Factors Studies and Related Clinical Study Considerations 4 May 2016
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USP General Chapters Prospectus 29 Mar 2016
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FDA eCTD Conformance Guide - Considerations for Combination Product 19 Jan 2016
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EMA Draft Guideline on Manufacture of the Finished Dosage Form 15 Jan 2016
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