Emergency Preparedness and Response

MCMi News and Events

collage of images illustrating medical countermeasures
News from the FDA Office of Counterterrorism and Emerging Threats (OCET), Medical Countermeasures Initiative (MCMi), and federal and industry partners. This page is updated frequently.

  • November 25, 2016: FDA is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Blood Products Advisory Committee for the Center for Biologics Evaluation and Research (CBER) notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative(s) to serve on the Blood Products Advisory Committee. Send letter of interest and/or nomination materials to FDA by December 23, 2016.

  • November 25, 2016: Draft guidance for industry - Submission of Quality Metrics Data (PDF, 340  KB) - to help develop compliance and inspection policies and practices, improve the Agency’s ability to predict, and therefore possibly mitigate, future drug shortages, and to encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing, FDA intends to initiate a quality metrics reporting program. The revised draft guidance describes FDA's plans for an initial, voluntary phase of this program. Comment by January 24, 2017. (Federal Register notice)

  • November 22, 2016: Guidance for industry - Contract Manufacturing Arrangements for Drugs: Quality Agreements (PDF, 123 KB) - describes FDA's current thinking on defining, establishing, and documenting manufacturing activities of the parties involved in contract drug manufacturing subject to current good manufacturing practice (CGMP) requirements (Federal Register notice)

  • November 16, 2016: FDA's Center for Drug Evaluation and Research (CDER) is announcing the 2017 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program. Pharmaceutical companies interested in participating in this program should submit a site visit proposal by January 17, 2017.

  • November 8, 2016: FDA is establishing a public docket to collect comments related to a proposed Study Data Standardization Plan (SDSP) template. To ensure that the Agency considers your comments in this review, submit comments by January 9, 2017. Also see the Pharmaceutical Users Software Exchange (PhUSE) SDSP template disclaimer icon (PDF, 74 KB)

  • October 14, 2016: Draft guidance - Software as a Medical Device (SaMD): Clinical Evaluation (PDF, 801 KB) - this draft guidance was prepared under the auspices of the International Medical Device Regulators Forum (IMDRF). It pertains to the conduct of clinical evaluation of SaMD and focuses on the general principles of clinical evaluation, which includes establishing the scientific validity, clinical performance, and analytical validity for a SaMD. The draft guidance is intended to provide globally harmonized principles of when and what type of clinical evaluation is appropriate based on the risk of the SaMD. Comment by December 13, 2016. (Federal Register notice)

  • September 16, 2016: HHS has issued a new regulation (final rule) and the National Institutes of Health (NIH) has issued a new policy to increase the availability of information about clinical trials via ClinicalTrials.gov. Regulations are effective as of January 18, 2017. (Federal Register notice) - also see: HHS takes steps to provide more information about clinical trials to the public (NIH press release) - video disclaimer icon (3:20) featuring Dr. Francis Collins, NIH
  • September 1, 2016: On November 9-10, 2016, FDA will hold a public hearing - Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products (Silver Spring, MD and webcast) - the purpose of this public hearing is to obtain comments on FDA's regulation of firms' communications about medical products, with a particular focus on firms' communications about unapproved uses of their approved/cleared medical products - to attend or present at the public hearing, register by October 19, 2016 - comments will be accepted until January 9, 2017

  • August 26, 2016: Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components; Guidance for Industry (PDF, 279 KB)

  • August 25, 2016: Final Guidance - Microbiological Data for Systemic Antibacterial Drug Products — Development, Analysis, and Presentation (PDF, 423 KB)

  • August 24, 2016: FDA is proposing to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach, referred to as a GLP Quality System, when safety and toxicity studies support or are intended to support applications or submissions for products regulated by FDA. As part of proposed changes to this rule, FDA seeks comment on the impact of expanding part 58 to include covered Animal Rule studies, and what other changes to the regulations, beyond amending the scope and definitions, are needed to address issues unique to covered Animal Rule studies. The comment period has been extended; comment by January 21, 2017.

  • View more MCM-related guidance information by topic on our Guidances and Other Information of Special Interest to MCM Sponsors page, or by date on our MCM-Related Guidance by Date page.  
  • Search all FDA guidance.
  • April 15, 2016: FDA alerts health care providers and emergency responders of expiration date extensions of certain auto-injectors manufactured by Meridian Medical Technologies. DuoDote, AtroPen, CANA, Morphine Sulfate, and Pralidoxime Chloride auto-injectors manufactured by Meridian Medical Technologies nearing or beyond their labeled or extended expiration dates should be retained until further guidance is provided by FDA. More about expiration dating extensions

  • February 1, 2016: FDA is working with drug makers in a new way to help the industry adopt scientifically sound, novel technologies to produce quality medicines that are consistently safe and effective — with an eye toward avoiding drug shortages. Read more in the FDA Voice blog.

  • September 15, 2015: Expiry date extensions of certain lots of doxycycline hyclate 100mg capsules held in strategic stockpiles (PDF, 28 KB) - memo to state and local public health and first responder stakeholders - related: doxycycline and penicillin G procaine for inhalational anthrax (post-exposure)
  • August 11, 2015: The Drug Shortages 2 app disclaimer icon is now available for Android devices on Google Play. Drug Shortages 2 includes an Alerts feature. You can opt in to receive notifications on your mobile device when FDA adds or updates shortage information about a drug product or one or more drugs within a selected therapeutic category. First launched March 4, 2015, the app identifies current drug shortages, resolved shortages and discontinuations of drug products. FDA is currently working on notifications for the iOS version of the mobile app. The app for Apple devices disclaimer icon is available for free download via iTunes.
  • July 8, 2015: FDA is amending its regulations to implement certain drug shortages provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). The rule requires all applicants of covered approved drugs or biological products—including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application—to notify FDA electronically of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the product in the United States.
  • April 2015: FDA has posted a new drug shortages infographic
  • For a complete list of drug shortages, view our Drug Shortages page or search the Drug Shortages Database  
 

 

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Page Last Updated: 12/02/2016
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