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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

  • January 26, 2023: FDA announces Evusheld is not currently authorized for emergency use in the U.S. - FDA revised the EUA (PDF) for Evusheld (tixagevimab co-packaged with cilgavimab) to limit its use to when the combined frequency of non-susceptible SARS-CoV-2 variants nationally is less than or equal to 90%. Based on this revision, Evusheld is not currently authorized for use in the U.S. until further notice by the Agency. 

    Should a patient become infected with SARS-CoV-2 and develop symptoms of COVID-19, they should seek medical attention, including starting treatment for COVID-19 as appropriate. There are several treatments – Paxlovid, Veklury (remdesivir) and Lagevrio (molnupiravir) – that are expected to work against currently circulating variants, and that are authorized or approved to treat certain patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death. Health care providers should assess whether treatments are right for their patients. Also see: Important prescribing information for health care providers (PDF, 135 KB)

    The U.S. Government recommends that facilities and providers with Evusheld retain all product in the event that SARS-CoV-2 variants which are neutralized by Evusheld become more prevalent in the U.S. in the future. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 769 KB) and the Letter of Authorization (PDF, 286 KB). Also see: Expiration Dating Extension - COVID-19 Therapeutics

  • January 26, 2023: Emergent Recalls Certain RSDL Kits Due to Leak Potential - Emergent is recalling RSDL (Reactive Skin Decontamination Lotion) kits from a specific batch after customers noted that some packets were leaking. The leak in the package could cause the lotion-bearing sponge to be less effective when used to remove or neutralize chemical warfare agents. Users also may be unnecessarily exposed to the lotion from leaked packages. The RSDL kit is an easy-to-open packet containing a sponge soaked with lotion. The RSDL kit is carried by members of the military and is intended to remove and/or neutralize chemical warfare agents and T-2 Toxin from the skin. FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries and/or serious health consequences.

  • January 25, 2023: MCMi email - Developers of drug and biological products for mpox: new draft guidance | Jan. 26 VRBPAC viewing info

  • January 20, 2023: FDA issued an immediately-in-effect guidance on compounding certain ibuprofen products in an effort to bolster supply of pediatric ibuprofen amid record high demand. The guidance clarifies FDA’s regulatory and enforcement priorities regarding the compounding of certain ibuprofen oral suspension products in outsourcing facilities for administration in hospitals and health systems.

  • January 19, 2023: FDA announced availability of a draft guidance for industry: Mpox: Development of Drugs and Biological Products. FDA is issuing this guidance to support sponsors in their development of drugs and biological products for mpox. This guidance provides nonclinical, virology, and clinical considerations for mpox drug and biological product development programs, with a focus on recommendations to support initiation of clinical trials. Preventive vaccines are not addressed in this guidance. Submit comments by March 21, 2023. 

  • January 18, 2023: MCMi email - Regulatory science funding deadline reminder | COVID-19 and mpox updates from FDA

  • January 13, 2023: CDC and FDA Identify Preliminary COVID-19 Vaccine Safety Signal for Persons Aged 65 Years and Older - No change in vaccination practice is recommended. Also see: COVID-19 Vaccine Safety Surveillance

  • January 12, 2023: FDA made minor updates to two COVID-19 testing guidances to help ensure continued access to tests while encouraging the transition of these important public health tools to traditional premarket review pathways. The updated guidances are:

    The minor updates to these guidances reflect FDA’s intent for the two guidances to remain in effect for the duration of the declaration under section 564 of the Federal Food, Drug, and Cosmetic Act that circumstances exist justifying Emergency Use Authorization (EUA) of in vitro diagnostics for the detection of COVID-19, rather than the duration of the public health emergency determination under section 319 of the Public Health Service Act relating to COVID-19. FDA also made minor edits to the Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests guidance to reflect current information about variants and actions the FDA has taken since the original issuance of this guidance.

  • January 11, 2023: MCMi email - COVID-19 variant updates | Pediatric disease modeling for long COVID

View more news in the MCMi News Archive

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