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  1. Medical Countermeasures Initiative (MCMi)

Guidance and Other Information of Special Interest to MCM Stakeholders

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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

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Indication-Specific Guidance (Drugs)

2019

  • August 2019: FDA released the updated version of the Clinical Outcome Assessment Compendium (COA Compendium) to encourage the development and implementation of patient-focused clinical outcome assessments (COAs) in clinical trials to support drug approvals and labeling claims. The COA Compendium is a communication tool that organizes and summarizes COA information for many different diseases and conditions into a single resource. FDA hopes this will facilitate communication with industry and researchers and provide clarity and transparency to drug developers and the research community. The COA Compendium is intended to be used as a starting point when considering how COAs might be utilized in clinical trials and will likely be most informative early in drug development.

  • June 2019: FDA announced the availability of a draft guidance for industry, M10 Bioanalytical Method Validation, that was developed by the International Council for Harmonisation. The draft guidance describes the various elements and expectations to validate specific tests used to measure the parent and active metabolites of drugs administered in nonclinical and clinical studies submitted in regulatory applications for biological matrices such as plasma, blood, or serum. Comment by August 26, 2019.

  • April 2019: FDA published a final guidance for government public health and emergency response stakeholders: Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles. This document provides guidance to government stakeholders on testing to extend the shelf life (i.e., expiration date) under the FD&C Act of stockpiled doxycycline tablets and capsules for public health emergency preparedness and response purposes for an anthrax emergency. This finalizes the draft guidance published on April 25, 2017. (Federal Register notice) More on Expiration Dating Extension

  • April 2019: FDA's Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). Interested pharmaceutical companies may send proposed agendas to CDER by June 3, 2019.

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Vaccines, Gene Therapies, and Cell Therapies (Biologics) 

2019

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Diagnostics, Medical Devices and Personal Protective Equipment (PPE)

2019

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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

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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)

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