U.S. Regulatory Issues
Plasma derived therapies are biological products, subject to regulation by the United States Food and Drug Administration and other government agencies around the world, such as the European Agency for the Evaluation of Medicinal Products. Regulatory authorities prescribe guidance documents, regulations and policy that can be highly detailed and technical, with a scope that covers everything from the collection of plasma through the advertisements and marketing of finished products. PPTA avails itself of opportunities to comment on government initiatives related to the plasma collection and fractionation industries, furthering the industry goal of rational regulatory policy that is based on sound scientific and technical grounds.
- Source Plasma Collection
- • Comments to FDA on Draft Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs.
- • Comments to FDA on Draft Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments.
- • Comments to FDA on Draft Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral
- • PPTA Statement on Management of Donors and Units that Test Positive for Hepatitis B Virus (HBV) DNA by Nucleic Acid Test (NAT)
- • Comments to FDA on Draft Guidance for Industry, "Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection" and Direct Final Guidance, “D
- • Response from FDA regarding 12/17/04 10 lbs. Weight Loss Letter
- • PPTA Letter Requesting Clarification of FDA's "Current Thinking" with Respect to Tracking Weight Loss in Plasma Donors. (December 2004)
- • Comments to FDA on Draft Guidance for Industry: Recommendations for Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin (IgG) Antibodies.
- • PPTA Statement on Review of Donor Weight Loss Monitoring (October 2004)
- • Comments to FDA on the "Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Using Screening Human Donors of Blood and Blood Components Draft Guidance." Part 2
- • PPTA Statement on Review of Donor Blood Pressure Requirements.
- • Comments to FDA on the Draft Guidance for Industry "Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Using Screening Human Donors of Blood and Blood Components Draft..
- • PPTA Statement of AABB Abbreviated Questionnaire
- • Comments to FDA on the Proposed Rule "Safety Reporting Requirements for Human Drug an Biological Products"
- • Comments to FDA on the Draft Guidance "Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis"
- Industry Issues Impacting Manufacturing Practices
- • Comments to FDA on FDA Public Workshop entitled, " Biological Products for Treatment of Rare Plasma Disorders, Addendum."
- • Comments to FDA on FDA Public Workshop entitled, " Biological Products for Treatment of Rare Plasma Disorders."
- • Comments to FDA on Draft Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Im
- • Comments to FDA on Draft Guidance for Industry: INDs - Approaches to Complying with cGMP During Phase 1.
- • Comments to FDA on Anti-Counterfeit Drug Initiative Workshop and Vendor Display.
- • Comments to FDA regarding From Concept to Consumer: Center for Biologics Evaluation and Research Working with Stakeholders on Scientific Opportunities for Facilitating Development of Vaccines, Blood a
- • Comments to FDA on Public Meeting and Whitepaper - Prescription Drug User Fee Act: Adding Resources and Improving Performance in FDA Review of New Drug Applications.
- • PPTA Statement on Update of Safety of Albumin
- • PPTA Statement on the Rare Bleeding Disorders Workshop
- • PPTA Letter to FDA Requesting Removal of 1998 "Dear Doctor Letter" Relating to Albumin from FDA's Website Based on Findings from SAFE Study (December 2004)
- • Comments to FDA on Improving Transparency in the CBER Regulatory Review Process. (December 2004)
- • Comments to the FDA on "Industry Representation on BPAC" (November 30,2004)
- • Comments to FDA on the Public Workshop, "Scientific Considerations Related to Developing Follow-On Protein Products" (November 12, 2004)
- • Comments to FDA on Solicitation of Comments on Stimulating Innovation in Medical Technologies.
- • Comments to FDA on Whitepaper "Innovation/Stagnation: Challenge and Opportunity on Critical Path to New Medical Products."
- • Comments to FDA on the Draft Guidance, "ICH E2E: Pharmacovigilance Planning (PvP) Draft Version 4.1 on 11th November, 2003."
- • PPTA Statement on Contributions of Manufacturing Processes to Prion Removal in the Production of Plasma-derived Therapeutics
- • Comments to FDA on the Proposal "Amending the MedWatch Forms to Collect Postmarketing Adverse Events Data Relating to Race and Ethnicity"
- • Comments to FDA on the Proposed Rule "Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma"
- • Comments to FDA on the Counterfeit Drug Task Force Interim Report
- • Comments to FDA on the Proposed Rule "Bar Code Label Requirements for Human Drug Products and Blood"