Latest PDA Regulatory Comments

• 2010: PDA Comments on Planning for the Effects of High Absenteeism to Ensure Availability of Medica
  PDA is pleased to offer comments on the draft Guidance for Industry, "Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products."
  
  
• 2010: PDA Comments on Current Good Manufacturing Practice Requirements for Combination Products
  PDA is pleased to offer comments on the prposed rule under 21 CFR Part 4, Docket No. FDA-2009-N-0435-0004 in the matter of "Current Good Manufacturing Requirements for Combination Products, f/k/a Docket No. FDA-2008-D-0409.
  
  
• PDA Comments on Postmarketing Safety Reporting for Combination Products / FDA-2008-N-0424
  PDA is pleased to offer comments on the proposed rule under 21 CFR Part 4, "Postmarketing Safety Reporting for Combination Products."
  
  
• PDA Comments on Recommendations for the Evaluation of Animal Cell Cultures as Substrates for the Man
  
• 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  PDA comments on the Draft Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use With Drugs and Biological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.
  
  
• 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
  
  
• 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  PDA comments on the Draft Guidance for Industry on Standards for Securing the Drug Supply chain -- Standardized Numerical Indentification for Prescription Drug Packages
  
  
• 2009: PDA Comments to EDQM Pharmaeuropa Chapter XXXX:2031
  PDA comments to EDQM on Pharmaeuropa Volume 21, No. 1, January 2009, proposed revisions to Chapter XXXX:2031, "Monoclonal Antibodies for Human Use."
  
  
• 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."
  
  
• 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  PDA’s official comments along with verbatim comments made by PDA members on the Draft Guidance for Industry on Process Validation: General Principles and Practices.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.
  
  
• 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
  
  
• 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
  
  
• 2008: PDA Comments on Draft Guidance for Parametric Release
  PDA comments on the Draft Guidance for Industry on Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes
  
  
• 2008: PDA Comments on EU Guidelines to GMP, Draft Annex 11 (Computerised Systems)
  PDA comments on the Draft Guidance EU Guidelines to GMP, Medicinal Products for Human and Veterinary Use, Draft Annex 11, Computerized Systems
  
  
• 2008: PDA Comments on EU Guidelines to GMP Chapter 4
  PDA comments on the Draft Guidance EU Guidelines to GMP, Medicinal Products for Human and Veterinary Use
  
  
• 2008: PDA Comments on ICH Q8
  PDA comments on the Draft Guidance ICH Q8 Annex, Pharmaceutical Development
  
  
• 2008: PDA Comments on GMP Draft Annex 2
  PDA Comments on GMP Draft Annex 2: Manufacture of Biological Medicinal Product for Human Use
  
  
• 2008: PDA Comments on Proposed Changes to Drug Product GMPs for Finished Pharmaceuticals
  PDA Comments on Proposed Changes to Drug Product GMPs for Finished Pharmaceuticals
  
  
• 2008: PDA Comments on ICH Draft Guidance on Q4B
  PDA Comments on Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 3 on Test Particulate Contamination: Subvisible Particles General Chapter