2009 PDA Regulatory Comments

PDA comments to EDQM on Pharmaeuropa Volume 21, No. 1, January 2009, proposed revisions to Chapter XXXX:2031, "Monoclonal Antibodies for Human Use."

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."

PDA is pleased to provide comments on the Concept Paper for the Implementation of ICH Q10 in the European GMP Guide.

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

PDA’s official comments along with verbatim comments made by PDA members on the Draft Guidance for Industry on Process Validation: General Principles and Practices.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.

PDA comments on the Draft Guidance EU Guidelines to GMP, Medicinal Products for Human and Veterinary Use, Draft Annex 13, Manufacture of Investigational Medicinal Products

PDA is pleased to provide comments on the Concept Paper for the Implementation of ICH Q10 in the European GMP Guide.

PDA comments on the Draft Guidance for Industry on Standards for Securing the Drug Supply chain -- Standardized Numerical Indentification for Prescription Drug Packages

PDA comments on Draft Guidance for Industry on Potency Testing of Cellular and Gene Therapy Products

PDA comments on the Draft Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use With Drugs and Biological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.