Medical Products Supply Chain Week in Review October 7, 2021

Medical Products Supply Chain Week in Review – October 7, 2021

Last week, the U.S.-EU Trade and Technology Council (TTC) held an inaugural meeting and discussed supply chain issues. The White House COVID-19 Response Team reported a decrease in case rates and hospitalizations. The FDA released multiple draft and final guidance documents, including a draft guidance for microbiological controls in nonsterile drug manufacturing. Johnson & Johnson asked the FDA to authorize its COVID-19 vaccine booster shot. Please see details for this and other supply chain developments below:

  • The Center for Devices and Radiological Health (CDRH) updated its listing of antigen diagnostic tests and molecular diagnostic tests for SARS-CoV-2 that are granted with emergency use authorization (EUA). The FDA continues to grant EUAs on a test-by-test basis since the conditions of authorization differ among manufacturers and laboratories.
  • On September 29, the FDA posted draft guidance “Microbiological Quality Consideration in Non-sterile Drug Manufacturing.” This document is meant to aid manufacturers in assessing their risks of microbiological contamination, CGMPs that are particularly relevant to microbiological control, and product development considerations. Comments are due by November 29, 2021.
  • On September 29, the FDA released an array of guidance documents relevant to product development:
    • Draft guidance “Benefit-Risk Assessment for New Drug and Biological Products” – The document is meant to provide sponsors and stakeholders with information on how the FDA utilizes a drug’s benefits, risks, and risk management factors to make New Drug Application (NDA) decisions. Comments are due by November 29, 2021.
    • Final guidance “Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations” – The document is meant to aid sponsors seeking to obtain an orphan-drug designation regarding the agency’s interpretation of the “sameness” to an existing gene therapy. Under the guidance, the FDA will generally consider two gene therapies to be different if they contain different principal molecular structure features. Minor differences will not disqualify a drug from being considered to be the same.
    • Draft guidance “Electronic Submission Template for Medical Device 510(k) Submissions” – The FDA seeks to develop a comprehensive set of technical standards to facilitate submission of a 510(k). The submission process will be completely electronic. Comments are due by November 28, 2021.
  • On September 29, the inaugural meeting of the U.S.-EU Trade and Technology Council (TTC) was held. In a joint statement, the council highlighted that it will seek to improve the economic and trade relationship between the U.S. and EU in many areas. One of the working groups is dedicated to securing the supply chain between the partners, and the group will focus on short-term supply chain issues first.
  • On September 30, the President proclaimed October 1 as National Manufacturing Day. In the proclamation, the President reaffirmed his commitment to strengthening the supply chain with new investments, including encouraging the government to purchase American-made products.
  • On October 1, Merck and Ridgeback Biotherapeutics announced interim analysis results of the clinical trial for molnupiravir, an oral COVID-19 antiviral drug, which demonstrated that the drug significantly reduced the risk of hospitalization and death in participants. Recruitment in the Phase 3 trial was stopped after review of the positive interim results by the data monitoring committee. In the treatment group, hospitalization or death occurred in 7.3% of the participants, compared with 14.1% in the placebo group. Merck plans to seek an EUA for the drug in the U.S. based on the interim results.
  • On October 5, Johnson & Johnson submitted a request to the FDA for the authorization of the booster shot of its COVID-19 vaccine.

Please do not hesitate to contact us if you have any questions about these developments.

Media Contact
Nicholas Clarke
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Phone: 212.210.1222

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