The latest U.S. FDA town hall for diagnostics included the usual technical questions about test validation, but there are some frustrations among test developers regarding turn-around times for emergency use authorizations (EUAs). Nonetheless, Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health (OIR) at the FDA, said the surge in staff assigned to review EUA filings has worked to some benefit, claiming that the agency has rendered a decision in connection with 65 applications in the two weeks leading up to the Dec. 9 town hall.
Calling it a “a critical milestone in its fight against COVID-19,” Health Canada authorized the Pfizer Inc./Biontech SE COVID-19 vaccine for people age 16 or older.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: USPTO finalizes SAS rule, U.S. senators press case for permanent telehealth, CMS no fan of national coverage policy for Allomap, TGA posts guidance for class I tests, Marburg MCMs protected under PREP.
The latest global regulatory news, changes and updates affecting biopharma, including: Sacklers threatened with House subpoena; DEA proposes de-scheduling Alkermes drug; Marburg MCMs protected under PREP; OPDP: Don’t make risks a P.S.; U.S. Senators sound off on E&M offsets.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 9 Meters, Albireo, Amryt, Bebig, Beigene, Citius, Chugai, Lipocine, Pfizer, Rafarma, Sinovac, Sorrento, Tricida, Tvax, United, Valeo.
TORONTO – Ontario and British Columbia med-tech companies have received CA$1.4 million (US$1 million) from Ottawa’s Supercluster fund, making a difference they said for patients suffering the long-range effects of COVID-19, chronic disease and undergoing joint replacement surgery.
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