Emergency Preparedness and Response
Guidances and Other Information of Special Interest to MCM Stakeholders
FDA develops guidance to provide its policy perspectives and recommendations on a wide variety of topics.
A comprehensive overview of FDA guidances is available on FDA’s Guidance Page.
The guidance documents below may be of special interest to existing or prospective medical countermeasure (MCM) sponsors, and other stakeholders, including state, tribal, local and territorial public health preparedness personnel.
May 2014: Product Development Under the Animal Rule (PDF, 2MB) (Draft) This revised draft guidance replaces the 2009 draft guidance for industry entitled “Animal Models--Essential Elements to Address Efficacy Under the Animal Rule” and addresses a broader scope of issues for products developed under the Animal Rule. Submit comments by August 4, 2014. (Federal Register notice )
May 2014: Draft Guidance for Industry on Clinical Pharmacology Data To Support a Demonstration of Biosimilarity to a Reference Product (PDF, 142 KB) - Submit comments by August 12, 2014 (Federal Register notice )
April 2014: Meetings with the FDA Office of Orphan Products Development (PDF, 92K) (Draft) (Federal Register notice )
March 2014: Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway (PDF, 169 KB) (Draft) (Federal Register notice )
December 2013: Comment period extended to January 2, 2014 - Guidance for Industry - Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products
June 2013: Expedited Programs for Serious Conditions--Drugs and Biologics (PDF, 252 KB) (Draft)
February 2012: Postmarket Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic (PDF, 218 KB)
October 2010: Qualification Process for Drug Development Tools (PDF, 190 KB) (Draft)
February 2000: Formal Meetings with Sponsors and Applicants for PDUFA Products (PDF, 30 KB)
April 2011: Influenza: Developing Drugs for Treatment and/or Prophylaxis (PDF, 417 KB)
November 2007: Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention (PDF, 242 KB) (Draft)
March 2006: Internal Radioactive Contamination - Development of Decorporation Agents (PDF, 177 KB)
March 2004: Potassium Iodide Shelf Life Extension; Guidance for Federal Agencies and State and Local Governments (PDF, 156 KB)
March 2004: Vaccinia Virus - Developing Drugs to Mitigate Complications from Smallpox Vaccination (PDF, 139 KB) (Draft)
January 2003: Prussian Blue Drug Products — Submitting a New Drug Application (PDF, 159 KB)
- December 2002: KI in Radiation Emergencies - Questions and Answers (PDF, 161 KB)
March 2002: Developing Drugs to Treat Inhalational Anthrax (Post-Exposure) (PDF, 250 KB) (Draft)
December 2001: Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies (PDF, 40 KB)
Calcium-DTPA and Zinc-DTPA, FDA encourages manufacturers to submit new drug applications (NDAs) for this product.
Vaccines, Gene Therapies, and Cell Therapies (Biologics)
July 2014: Providing Submissions in Electronic Format-Postmarketing Safety Reports for Vaccines (Draft). Submit comments by September 16, 2014. (Federal Register notice )
February 2010: 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 (PDF, 406 KB)
September 2007: Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms (PDF, 184 KB)
November 2007: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications (PDF, 88 KB)
Devices (Diagnostics and Medical Devices)
Device advice: comprehensive regulatory assistance (from CDRH), including How to Market Your Device
July 2014: FDA launched a new learning tool for academic institutions and science and technology innovators called the National Medical Device Curriculum, to advance understanding of FDA's medical device regulatory processes.
May 2014: FDA is proposing the reclassification of antigen based rapid influenza detection test (RIDT) systems intended to detect influenza virus antigen directly from clinical specimens that are currently regulated as influenza virus serological reagents from class I into class II with special controls and into a new device classification regulation. Submit comments (identified by Docket No. FDA-2014-N-0440) by August 20, 2014 at http://www.regulations.gov . More information is available in the Federal Register notice .
April 2014: Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions (Draft); FDA news release about this draft guidance
November 2013: Design Considerations for Pivotal Clinical Investigations for Medical Devices - Guidance for Industry, Clinical Investigators, Institutional Review Boards and Food and Drug Administration Staff - Presentation on this guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices (PDF, 270 KB)
November 2011: In Vitro Diagnostic Devices for Yersinia spp. Detection Class II Special Congrols Guidance Document (PDF, 173 KB) (Draft)
Other Information of Interest (press releases, notices, etc)
For Industry: Using Social Media (draft gudiance); slides from July 10, 2014 webinar (PDF, 157 KB) about this draft guidance; social media draft guidance webinar Q&As (PDF, 97 KB); submit comments on draft guidance by September 16, 2014 (Federal Register notice )
July 16, 2014: Federal Register notice: Collection of Information - Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile (SNS) . Respondents to this collection of information are entities that manufacture (including labeling, packing, relabeling, or repackaging), distribute, or store affected SNS products. Fax written comments on this collection of information by August 15, 2014.
June 5, 2014: Final rule - list of qualifying pathogens under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act (FDASIA). GAIN is intended to encourage development of new antibacterial and antifungal drugs for the treatment of serious or life-threatening infections, and provides incentives such as eligibility for designation as a fast-track product and an additional 5 years of exclusivity to be added to certain exclusivity periods.
FDA has determined that the following pathogens comprise the list of “qualifying pathogens:” Acinetobacter species, Aspergillus species, Burkholderia cepacia complex, Campylobacter species, Candida species, Clostridium difficile, Coccidioides species, Cryptococcus species, Enterobacteriaceae (e.g., Klebsiella pneumoniae), Enterococcus species, Helicobacter pylori, Mycobacterium tuberculosis complex, Neisseria gonorrhoeae, N. meningitidis, Non-tuberculous mycobacteria species, Pseudomonas species, Staphylococcus aureus, Streptococcus agalactiae, S. pneumoniae, S. pyogenes, and Vibrio cholerae. For more information, view the Federal Register notice
April 10, 2014: Federal Register notice - FDA seeks comments on a collection of information on the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without consent. Comments due June 9, 2014.
February 2014: Study Data Technical Conformance Guide (PDF, 255 KB) - Technical Specifications Document; see also Guidance for Industry (Draft) - Providing Regulatory Submissions in Electronic Format - Standardized Study Data (PDF, 231 KB)
June 19, 2013: FDA Safety and Innovation Act presentation (PDF, 791 KB), including information on the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safetey and Innnovation Act (FDASIA), and Qualified Infectious Disease Product (QIDP) designation (see Title VIII - GAIN, starting on slide 8)
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
Revision of the Requirements for Live Vaccine Processing (21 CFR 600.11) (2007)