Resources

• Final Submission of PDA Comments for Draft EMA Guideline on Process Validation_30Oct2012
  PDA provided comments to EMA's draft "Guideline on Process Validation," October 30, 2012.
• Final Submission PDA Comments Draft Guidance on Biosimilar Q&A INNACT 2009 20120413
  PDA provided comments to FDA’s Draft Guidance for Industry on Biosimilars, “Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009,” April 13, 2012.
• Final Submission PDA Comments to Draft Guidance on Biosimilar Quality 20120412
  PDA provided comments to the FDA’s Draft Guidance for Industry, “Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product,” April 13, 2012.
• Final Submission PDA Comments to Draft Guidance on Biosimilar Scientific 20120413
  PDA provided comments to the FDA’s Draft Guidance for Industry, “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product”, April 13, 2012.
• PDA Consultation Delegated Act Final Apr 20 2012
  PDA provides consultation on the “Delegated Act the Principles and Guidelines of Good Manufacturing Practice” (GMP) for Active Substances in Medicinal Products for Human Use” concept paper on April 20, 2012.