FDA Law Blog
AUGUST 4, 2022
Pfizer manufactures tafamidis, a breakthrough treatment for a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. On June 27, 2019, Pfizer sought an OIG advisory opinion to ensure that its proposal would not run afoul of federal law. Background.
FDA Law Blog
NOVEMBER 1, 2023
Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.
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GeriPal
MAY 8, 2025
Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. This is Eric Widera.
FDA Law Blog
NOVEMBER 22, 2022
Gaulkin — At the risk of ruining our readers’ appetite for America’s most food-focused holiday, foodborne illnesses have been a feature of Thanksgiving for some time now. When foodborne illness outbreaks arise, efficient traceability is critical to prevent illnesses, death, and unnecessary product loss. coli contamination.
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