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Parenteral Drug Association
Connecting People, Science and Regulation
®
Parenteral Drug Association
Connecting People, Science and Regulation
®
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2009 PDA Regulatory Comments
2009 PDA Comments to EDQM Pharmaeuropa Chapter XXXX2031
PDA comments to EDQM on Pharmaeuropa Volume 21, No. 1, January 2009, proposed revisions to Chapter XXXX:2031, "Monoclonal Antibodies for Human Use."
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2009 PDA Comments to EDQM on Pharmaeuropa Chapters 2-6-16 and 5-2-3
PDA comments on Pharmaeuropa Volume 21, No. 1, January 2009 on Proposed Revisions to Chapter 2.6.16, "Test for Extraneous Agents in Biological Products," and Chapter 5.2.3, "Cell Substrates for the Production of Biological Products."
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2009 PDA Comments to Concept Paper on the Revision of the EU Guideline on GDP
PDA is pleased to provide comments on the Concept Paper for the Implementation of ICH Q10 in the European GMP Guide.
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2009 PDA Comments on the Revised TSE Note for Guidance
PDA comments on the Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products (Doc. Ref. EMEA/410/10/01 -- Rev. 4, 21 February 2008
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2009 PDA Comments on the Process Validation Guidance
PDA’s official comments along with verbatim comments made by PDA members on the Draft Guidance for Industry on Process Validation: General Principles and Practices. Verbatim comments submitted by PDA Members have not been approved by the PDA Regulatory Affairs and Quality Committee or the PDA Board of Directors. They do not reflect official PDA comments. They are provided for educational proposes only.
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2009 PDA Comments on EU Guidelines to GMP Draft Annex 13
PDA comments on the Draft Guidance EU Guidelines to GMP, Medicinal Products for Human and Veterinary Use, Draft Annex 13, Manufacture of Investigational Medicinal Products
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2009 PDA Comments on the Concept Paper for Implementation of ICHQ10
PDA is pleased to provide comments on the Concept Paper for the Implementation of ICH Q10 in the European GMP Guide.
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2009 PDA Comments on Recommendations for the Evaluation of Animal Cell Cultures as Substrates for the Manufacture of Biological Medicinal Products and for the Characterization of Cell Banks
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2009 PDA Comments on Securing the Drug Supply Chain
PDA comments on the Draft Guidance for Industry on Standards for Securing the Drug Supply chain -- Standardized Numerical Indentification for Prescription Drug Packages
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2009 PDA Comments on Draft Guidance on Potency Testing of Cellular and Gene Therapy Products
PDA comments on Draft Guidance for Industry on Potency Testing of Cellular and Gene Therapy Products
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2009 FDA Comments on Federal Docket Management System Docket FDA-2009-D-0179
PDA comments on the Draft Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use With Drugs and Biological Products.
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