U.S. flag An official website of the United States government
  1. Home
  2. Emergency Preparedness and Response
  3. Counterterrorism and Emerging Threats
  4. Medical Countermeasures Initiative (MCMi)
  5. MCM Legal, Regulatory and Policy Framework
  6. Guidance and Other Information of Special Interest to MCM Stakeholders
  1. Medical Countermeasures Initiative (MCMi)

Guidance and Other Information of Special Interest to MCM Stakeholders

Guidance and Other Information of Special Interest to MCM Stakeholders

Image
Compass on wooden background, representing the concept of guidance

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. 

Search all FDA guidance FDA guidance overview MCM-related guidance by date 

For additional guidance and industry announcements from previous years, please visit our archives, available by topic and by date.
On this page:

General Guidance

Indication-Specific Guidance (Drugs)

Vaccines, Gene Therapies, and Cell Therapies (Biologics)

Diagnostics, Medical Devices and Personal Protective Equipment (PPE)

Pediatric Guidance of Interest to MCM Stakeholders

Other Information of Interest (press releases, notices, etc.)

General Guidance

2019

Select MCM-related guidance prior to 2019

back to top

Indication-Specific Guidance (Drugs)

2019

Select MCM-related guidance prior to 2019

back to top

Vaccines, Gene Therapies, and Cell Therapies (Biologics) 

2019

Select MCM-related guidance prior to 2019

back to top

Diagnostics, Medical Devices and Personal Protective Equipment (PPE)

2019

Select MCM-related guidance prior to 2019

back to top

Pediatric Guidances of Interest to MCM Stakeholders

Also see the Pediatric Medical Countermeasures guidance page from CDER, including considerations for bioterrorism and radiation emergencies.

2019

Select MCM-related guidance prior to 2019

back to top

Other Information of Interest (press releases, notices, etc.)

2019

Select MCM-related guidance prior to 2019

  • November 2018: FDA is posting links to computer code and a roadmap that will allow researchers and developers to customize and use the newly created MyStudies app. Patients can securely enroll and participate in large scale pragmatic clinical trials or registries involving multiple health care systems or data sources.  The agency expects that the MyStudies app will aid researchers and industry in collecting real world patient level data and that these data, when linked to existing electronic health data, will promote efficiencies in drug development and drug safety monitoring processes. The MyStudies app is also capable of supporting clinical trials that comply with FDA guidance and regulations regarding data authenticity, integrity, and confidentiality. Also see: FDA In Brief: FDA launches new digital tool to help capture real world data from patients to help inform regulatory decision-making

  • September 2018: FDA announced the fee rate for using a material threat medical countermeasure priority review voucher (MCM PRV) for fiscal year (FY) 2019. Also see: MCM priority review voucher program

  • July 2018: FDA issues policy to facilitate the use of electronic health record data in clinical investigations - FDA published a guidance for industry, Use of Electronic Health Record Data in Clinical Investigations (PDF, 327 KB). The guidance provides recommendations for sponsors, clinical investigators, contract research organizations (CROs), institutional review boards (IRBs), and other interested parties on the use of electronic health record (EHR) data in FDA-regulated clinical investigations.

  • April 2018: FDA is conducting a Model-Informed Drug Development (MIDD) Pilot Program to facilitate the development and application of exposure-based, biological, and statistical models derived from preclinical and clinical data sources. MIDD approaches use a variety of quantitative methods to help balance the risks and benefits of drug products in development. When successfully applied, MIDD approaches can improve clinical trial efficiency, increase the probability of regulatory success, and optimize drug dosing/therapeutic individualization in the absence of dedicated trials. FDA will accept requests to participate in the program on a continuous basis beginning on April 13, 2018 through June 15, 2022. See the Federal Register notice for additional information.

  • January 2018: FDA launched a new set of web pages that aims to provide a one-stop source for general information about Risk Evaluation and Mitigation Strategy (REMS) programs.

  • October 2017: FDA Issues Final Guidance Clarifying FDA and EPA Jurisdiction over Mosquito-Related Products - The final Guidance for Industry #236 – Clarification of FDA and EPA Jurisdiction over Mosquito-Related Products (PDF, 85 KB) – clarifies that mosquito-related products intended to function as pesticides by preventing, destroying, repelling, or mitigating mosquitoes for population control purposes, and that are not intended to cure, mitigate, treat, or prevent a disease are not “drugs” under the Federal Food, Drug, & Cosmetic Act, and will be regulated by the EPA under the Federal Insecticide, Fungicide, and Rodenticide Act. The FDA will continue to have jurisdiction over mosquito-related products that are intended to prevent, treat, mitigate, or cure a disease (including by an intent to reduce the level, replication, or transmissibility of a pathogen in mosquitoes). (Federal Register notice) Also see Genetically Engineered Mosquitoes on the FDA Zika Response Updates page

  • June 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 disclaimer icon  Also see January 2018 draft guidance: QIDP Designation Questions and Answers (PDF, 390 KB). Comment by April 2, 2018. (Federal Register notice) and statement from Janet Woodcock, MD on examining ways to combat Antibiotic Resistance and Foster New Drug Development (June 14, 2016)

back to top

Related Links

Subscribe

Sign up to receive email alerts on emergency preparedness and response topics from FDA, including guidance related to medical countermeasures and emerging infectious diseases.