FDA Law

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.

Manufacturing 105

Manufacturing Management Complication Provider 105

FDA Law

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”).

Provider 59

Provider IT Manufacturing Complication 59

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. As always, DEFINITELY please let us know how the stuff we provide can be even better. And he liked what he saw.

Insurance 52

Insurance IT Board-Certified Medical 52

FDA Law

MAY 21, 2024

The Attorney General also released DOJ’s Office of Legal Counsel (“OLC”) opinions providing the rationale and support for the NPRM. 29, 2023) (“Basis”); NPRM at 44,603. In 2023, HHS conducted a different approach, a two-part test, to determine whether marijuana has a CAMU. 44,597 (May 21, 2024). NPRM at 44,607.

Physicals 69

Physicals Medical Clinic Emergency Room 69