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MCMi News and Events

Medical countermeasure and public health emergency news and events from FDA and partners

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Featured news and events

  • March 22, 2023: MCMi email - COVID-19 and mpox testing updates | Data standards for Animal Rule studies

  • March 17, 2023: FDA issued an EUA (PDF, 257 KB) for the Cue Mpox (Monkeypox) Molecular Test for use in a point-of-care (POC) setting. The Cue Mpox (Monkeypox) Molecular Test is molecular-based test intended to detect monkeypox virus DNA in lesion swab specimens from individuals suspected of mpox by their health care provider. Learn more: Monkeypox (mpox) Emergency Use Authorizations for Medical Devices

  • March 17, 2023: The FDA Center for Drug Evaluation and Research (CDER) Office of Compliance published its 2022 Annual Report (PDF, 6.3 MB), including a spotlight on the office's activities to support public health emergency response.

  • March 16, 2023: FDA updated the page Medical Device Shortages During the COVID-19 Public Health Emergency to reflect changes to expected shortage durations for several types of products, and add devices to the device discontinuance list. 

  • March 15, 2023: The HHS Secretary amended the February 4, 2020 determination made pursuant to section 564 of the FD&C Act and determined pursuant to his authority under section 564(b)(1)(C) that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad and that involves a biological agent, namely the novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (SARS-CoV-2). 

    The four previously-issued section 564 declarations that refer to the February 4, 2020 determination have not been terminated by the Secretary because, among other things, the circumstances described in section 564(b)(1) continue to exist—i.e., COVID-19, a disease attributable to SARS-CoV-2, continues to present a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad. Consistent with section 564(f), the currently-in-effect EUAs issued under those section 564 declarations remain in effect until the earlier of the termination of relevant section 564 declarations under section 564(b), or revocation of the EUAs. Therefore, these EUAs, including for tests, other devices, treatments, and vaccines, continue to remain in effect. Also see: FAQs: What happens to EUAs when a public health emergency ends? and the March 20, 2023, Federal Register notice: COVID-19 Emergency Use Authorization Declaration

  • March 15, 2023: FDA announced a final guidance, Definitions of Suspect Product and Illegitimate Product for Verification Obligations, as part of the agency’s implementation of the Drug Supply Chain Security Act (DSCSA). The guidance clarifies FDA’s interpretation of specific terms used in the definitions of “suspect product” and “illegitimate product” to assist trading partners in meeting verification obligations (including notification). The specific terms discussed in the guidance are counterfeit, diverted, stolen, fraudulent transaction, and unfit for distribution. This guidance replaces the draft guidance of the same name. The DSCSA establishes requirements for product tracing, verification, and product identification for certain drug products that are distributed in the U.S. to enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. These requirements add safeguards to improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers. 

  • March 15, 2023: MCMi email - COVID-19-related guidance documents update | FDA permits marketing of first COVID-19 antigen test using traditional premarket review process

  • March 14, 2023: FDA Authorizes Bivalent Pfizer-BioNTech COVID-19 Vaccine as Booster Dose for Certain Children 6 Months through 4 Years of Age - FDA amended the EUA of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide for a single booster dose of the vaccine in children 6 months through 4 years of age at least 2 months after completion of primary vaccination with three doses of the monovalent (single strain) Pfizer-BioNTech COVID-19 Vaccine.    

  • March 13, 2023: CDER Conversation – The Latest in Drug Shortages - Drug shortages can occur for many reasons, including manufacturing and quality problems, production delays, and product discontinuations. Manufacturers provide FDA with information related to potential drug shortages, and the agency works closely with them to prevent or reduce the impact of shortages. In this CDER Conversation Emily Thakur, CDR, U.S. Public Health Service, Team Leader for the Center for Drug Evaluation and Research (CDER) Drug Shortage Staff, talks about recent drug supply challenges, shares new FDA guidance, and offers solutions to mitigate drug shortages.

  • March 13, 2023: Expanded Access with Dr. Jacqueline Corrigan-Curay (Q&A with FDA podcast and transcript) - In this podcast, Dr. Jacqueline Corrigan-Curay, Principal Deputy Director of DER, discusses Expanded Access to Investigational Drug Products. CDER’s DDI receives many questions on this topic. In the past year, DDI has responded to over 750 expanded access related inquiries.

  • March 10, 2023: FDA issued a notice addressing the agency’s COVID-19-related guidance documents, including which of those guidance documents will no longer be in effect after the expiration of the COVID-19 public health emergency (PHE) declared under the Public Health Service (PHS) Act, and which of those guidance documents FDA is revising to temporarily continue in effect. This notice follows an announcement from the U.S. Department of Health and Human Services that, based on current COVID-19 trends, the Department is planning for the COVID-19 PHE declared under the PHS Act to expire on May 11, 2023. 

    Since the start of the COVID-19 PHE [declared under the PHS Act], FDA has been committed to providing timely recommendations and regulatory information to support response efforts. During the COVID-19 PHE declared under the PHS Act, FDA has provided important tools and flexibilities to manufacturers, health care facilities, providers, patients, and other stakeholders. Importantly, the ending of the PHE declared by HHS under the PHS Act will not impact the FDA’s ability to authorize devices (including tests), treatments or vaccines for emergency use. Existing emergency use authorizations (EUAs) for products will remain in effect and the agency may continue to issue new EUAs going forward when criteria for issuance are met. FDA remains committed to providing notice and information to all impacted stakeholders to ensure a smooth transition. 

  • March 9, 2023: The CDER and CBER Drug Development Tool Qualification Project Search database is now available. The database provides information on clinical outcome assessment (COA) projects for which qualification has yet to be determined, including FDA’s decision to accept or not accept the submission, and FDA’s recommendations on further COA development. The database is a great resource for locating similar measurement development efforts and example submissions. Contact COADDTQualification@fda.hhs.gov with questions.

  • March 9, 2023: FDA recently posted these new videos (YouTube): Do the COVID-19 vaccines make people more susceptible to emerging variants? and Why should I get my child an updated COVID-19 vaccine? 

  • March 8, 2023: FDA permits marketing of first COVID-19 antigen test using traditional premarket review process - FDA granted marketing authorization (PDF, 253 KB) of the Sofia 2 SARS Antigen+ FIA, Sofia SARS Antigen FIA Control Swab Set, intended for prescription use only for the detection of the COVID-19 virus within 6 days of symptom onset and which can be used in a point-of-care setting. The test aids in the diagnosis of COVID-19 for people experiencing symptoms and is to be repeated twice over three days with at least 48 hours between tests.

  • March 8, 2023: MCMi email - Advanced manufacturing updates | Register now for March and April events 

  • March 7, 2023: CDRH Statement on Emergency Use Authorization of Lucira Health’s COVID-19 & Flu Home Test

  • March 3, 2023: FDA approved (PDF, 296 KB) a new single-dose prefilled auto-injector presentation of Udenyca (pegfilgrastim-cbqv) to increase survival of adult and pediatric patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome, or H-ARS) as could occur after a radiological or nuclear event. For more information, see the product label (PDF, 1.3 MB).

  • March 2, 2023: FDA issued a draft guidance, Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens. This guidance provides drug manufacturers with recommendations for developing and implementing potency assays to ensure each lot of monoclonal antibodies (mAbs) or other therapeutic proteins is produced consistently with the potency necessary to achieve efficacy and that potency is maintained over the shelf life of the product. In January 2021, FDA published a guidance specific to potency considerations for mAbs and therapeutic proteins targeting SARS-CoV-2 (the virus causing COVID-19). This draft guidance expands the scope of the January 2021 guidance to include all mAbs and other therapeutic proteins targeting viruses, not just mAbs targeting SARS-CoV-2. Submit comments by May 1, 2023

  • March 1, 2023: FDA issued the ICH final guidance, Q13 Continuous Manufacturing of Drug Substances and Drug Products and a discussion paper for stakeholder comment, Discussion Paper: Artificial Intelligence in Drug Manufacturing (PDF, 1.7 MB). These documents represent proactive steps FDA is taking to facilitate the pharmaceutical industry’s adoption of these advanced manufacturing technologies. FDA has long supported advanced manufacturing technologies that might improve process quality and address underlying causes of drug shortages and recalls. FDA is asking interested stakeholders to provide input on certain areas of consideration identified in the discussion paper by May 1, 2023.

  • March 1, 2023: MCMi email - FDA authorizes first over-the-counter at-home test to detect both influenza and COVID-19 viruses

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