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Parenteral Drug Association
Connecting People, Science and Regulation
®
Parenteral Drug Association
Connecting People, Science and Regulation
®
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2018 PDA Regulatory Comments
PDA Response to EDQM Proposed EP 5.17.2. Recommendations on Testing of Particulate Contamination 28 Dec 2018
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PDA Response to EDQM Revision of EP 5.1.5 Application of F Concepts to Heat Sterilisation 28 Dec 2018
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PDA Response to ICH Q12 Health Canada 10 Aug 2018
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PDA Response to FDA Draft Guidance on CMCs for Gene Therapy INDs 6 Dec 2018
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PDA Response to FDA Request for Regulation and Paperwork Reduction 13 Apr 2018
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PDA Response to FDA Draft Guidance on Testing Gene Therapy Products for RCR 6 Dec 2018
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PDA Response to EMA EU Template for GMP Non-Compliance Statement 15 May 2018
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PDA Response to EMA QP and API Site Audit Questions 2 May 2018
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PDA Response to ANVISA Stability Revised Guidance 5 Apr 2018
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PDA Response to FDA CMC Changes for Certain Biological Products 22 Mar 2018
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PDA Response to Annex 1 Revision: Manufacture of Sterile Medicinal Products 20 Mar 2018
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PDA Response to Israel MOH Draft QP SOP 1 Mar 2018
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PDA Response to USP Changes to COE Rules 7 Jan 2018
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