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. 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.
A comprehensive overview of FDA guidances is available on FDA’s Guidance Page.
Other information of interest (press releases, notices, etc.)
February 2015: Draft Guidance for Industry - Individual Patient Expanded Access Applications: Form FDA 392 (PDF, 473 KB) - Related: read a blog post about how this new form will help FDA streamline expanded access to investigational drugs; learn more about expanded access (compassionate use), including information for patients, physicians and industry
January 2015: Current Good Manufacturing Practice Requirements for Combination Products - more about combination products
December 2014: Draft Guidance for Industry - General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products (PDF, 375 KB)- submit comments by February 9, 2015 (Federal Register notice)
December 2014: Guidance for Industry - Drug Supply Chain Security Act (DSCSA) Implementation--Product Tracing Requirements (PDF, 56 KB) - This guidance provides information pertaining to statutory requirements that will take effect on January 1, 2015, regarding the provisions to provide and capture product tracing information under section 582(b)(1), (c)(1), and (e)(1) of the FD&C Act. More about the DSCSA. (Federal Register notice)
December 2014: Guidance for Industry - Providing Regulatory Submissions in Electronic Format--Standardized Study Data (PDF, 124 KB) - CDER and CBER
December 2014: Guidance for Industry - Providing Regulatory Submissions in Electronic Format--Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act (PDF, 81 KB) - CDER and CBER
May 2014: Product Development Under the Animal Rule (PDF, 2MB) (Draft) This revised draft guidance replaces the 2009 draft guidance for industry entitled “Animal Models--Essential Elements to Address Efficacy Under the Animal Rule” and addresses a broader scope of issues for products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. (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: 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) - FDA response to comments on this guidance (January 6, 2015)
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)
Indication-Specific Guidances (Drugs)
Search all guidances (Drugs)
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)
Search all guidances (Biologics)
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)
Diagnostics and Medical Devices
Device advice: comprehensive regulatory assistance (from CDRH), including How to Market Your Device
December 2014: Radiation Biodosimetry Devices (Draft Guidance) (PDF, 379 KB) - FDA has developed this draft guidance to facilitate study designs to establish the analytical and clinical performance characteristics of radiation biodosimetry medical countermeasure devices. Radiation biodosimetry countermeasure devices are devices used for the purpose of reconstructing the ionizing radiation dose received by individuals or populations using physiological, chemical or biological markers of exposure found in humans. Comments due March 30, 2015. (Federal Register notice)
November 4, 2014: CDRH Industry Basics Workshop - view presentations from this webinar, including IDE Basics, 510(k), De Novo program, CAPA basics, and medical device reporting (21 CFR Part 803)
October 2014: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (Federal Register notice ) (press release) - October 29, 2014 webinar on this guidance: recorded webinar (video/audio), printable slides (PDF, 227 KB), transcript (PDF, 256 KB)
August 2014: Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices (PDF, 799 KB)
August 2014: FDA Decisions for Investigational Device Exemption Clinical Investigations (PDF, 631 KB)
August 2014: Unique Device Identification System: Small Entity Compliance Guide (PDF, 518 KB); Unique Device Identifier System: Frequently Asked Questions, Vol. 1 (PDF, 726 KB); more information on Unique Device Identification (UDI)
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. 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)
Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance - Records and Reports
Study data standards resources, including Study Data Technical Conformance Guide v2.0 (December 17, 2014)
December 18, 2014: Proposed rule - Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products - FDA is proposing to amend prescription drug and biological product labeling regulations to require electronic distribution of the prescribing information intended for health care professionals, which is currently distributed in paper form on or within the package from which a prescription drug or biological product is dispensed, to help ensure that the most current prescribing information is publicly accessible for the safe and effective use of human prescription drugs. Submit comments by March 18, 2015.
November 24, 2014: FDA has developed Drug Trials Snapshots to provide information to the public about who participated in the clinical trials for new FDA-approved drugs. Drug Trials Snapshot is part of a pilot project to provide information about the sex, age, race and ethnicity of clinical participants for a small group of recently approved drugs. (Federal Register notice)
November 21, 2014: Clinical Trials Registration and Results Submission (Federal Register notice) - HHS is seeking input on a proposed rule to update how data that were collected and analyzed in accordance with a clinical trial's protocol are to be submitted to ClinicalTrials.gov. Read a news release and summary of changes from NIH. Comments are due by February 19, 2015.
- 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.
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
- 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)