FDA Law Blog
SEPTEMBER 11, 2024
Nitrosamines are impurities that can form during drug manufacturing and are considered potentially potent carcinogens. For example, depending on the manufacturing process for a specific human drug, the use of some specific solvents, reagents, and catalysts may trigger the formation of these possible carcinogens.
FDA Law Blog
JANUARY 11, 2024
Koblitz — Back in late September 2023 (and corrected in October), FDA issued its first interchangeable exclusivity determination pursuant to the Biologics Price Competition and Innovation Act (“BPCIA”). Thus, 18 months from approval would result in expiration of FIE on April 15, 2023, and on September 18, 2023 respectively.
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Physician's Weekly
JUNE 19, 2025
About 3 in 10 adults reported not taking their medicines as prescribed at some point between July 2022 and July 2023 because of the cost, according to a KFF survey. Dan: Another addition: Manufacturer coupons. If I offered you $30 million for the company, would you take it? And he liked what he saw. Dan: Oh man, tell me about it.
FDA Law Blog
MAY 21, 2024
29, 2023) (“Basis”); NPRM at 44,603. DEA noted that “there is considerable variability in the cannabinoid concentrations and chemical constituency among marijuana samples and that the interpretation of clinical data related to marijuana is complicated.” NPRM at 44,607. Denial of Petition at 53,700-02; Denial of Petition at 53,779-81.
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