Emergency Preparedness and Response
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Guidances and Other Information of Special Interest to MCM Sponsors
FDA’s Medical Countermeasures initiative (MCMi) is making the following guidance and other relevant information available on its web site. This information may be of special interest to existing or prospective MCM sponsors.
Guidance Documents
FDA develops guidance to provide its policy perspectives and recommendations on a wide variety of topics related to FDA-regulated products. A comprehensive overview of FDA guidances is available on FDA’s Guidance Page. The following guidances may be of special interest to prospective Medical Countermeasures sponsors.
General Guidances
- Qualification Process for Drug Development Tools (Draft)
- Animal Models – Essential elements to Address Efficacy Under the Animal Rule (Draft)
- Postmarket Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic
- Formal Meetings with Sponsors and Applicants for PDUFA Products
- Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products
- Emergency Use Authorization of Medical Products
Indication Specific Guidances
- Internal Radioactive Contamination - Development of Decorporation Agents
- Prussian Blue Drug Products — Submitting a New Drug Application
- Calcium-DTPA and Zinc-DTPA, FDA encourages manufacturers to submit new drug applications (NDAs) for this product.
- Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies
- KI in Radiation Emergencies - Questions and Answers
- Potassium Iodide Shelf Life Extension; Guidance for Federal Agencies and State and Local Governments
- Developing Drugs to Treat Inhalational Anthrax (Post-Exposure (Draft)
- Vaccinia Virus - Developing Drugs to Mitigate Complications from Smallpox Vaccination (Draft)
- Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention (Draft)
- Influenza: Developing Drugs for Treatment and/or Prophylaxis
- Clinical Data Needed to Support Licensure of Pandemic Influenza Vaccines
- Clinical Data Needed to Support Licensure of Trivalent Inactivated Influenza Vaccines
Vaccines, Gene Therapies, and Cell Therapies
- Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms
- Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
- Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications
- Characterization and Qualification of Cell Substrates and other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
Diagnotic Devices
- In Vitro Diagnostic Devices for Yersinia spp. Detection Class II Special Congrols Guidance Document (Draft)
- Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or the Detection and Differentiation of Influenza Viruses
Other Information of Interest (press releases, notices, etc)
- April 27, 2012, FDA approves antibacterial treatment for plague. Press release.
- Revision of the Requirements for Live Vaccine Processing (21 CFR 600.11) (2007)
- Amendments to Sterility Test Requirements for Biological Products (21 CFR 600.3(q), 21 CFR 610.12, 21 CFR 680.3) (2012)
- Regulatory Pathways Supporting Development and Approval of Vaccines Formulated with Novel Adjuvants, presentation at the Vaccine Forum, Washington, D.C., January 2012
- FDA amends its regulation to provide for approval of certain new pharmaceutical products based on animal efficacy data.
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