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Following on the heels of a House subcommittee meeting to discuss FDA inspections of foreign drug manufacturers, the FDA released a scathing 483 inspection report of an active pharmaceutical ingredient (API) manufacturer in China. Read More
Wayne Pines, Senior Director at APCO Worldwide, a former associate commissioner of the FDA, and a member of the FDAnews Editorial Board, reviews the FDA’s recent actions related to marketing of drug products both to healthcare professionals and to consumers. Read More
During the second session of the 118th Congress, FDAnews will track pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
Approved BLAs may continue to incorporate by reference information on drug substances, drug substance intermediates, and drug products (DS/DSI/DP) contained in master files if the data were initially referenced when the application was approved, according to a final rule issued by the FDA. Read More
Novo Nordisk achieved settlements that force two clinics to cease selling unapproved versions of the company’s semaglutide products and explain in their marketing materials that unapproved compounded drugs have not been evaluated or approved by the FDA. Read More
Over the past week, the FDA issued final guidance on reporting drugs and biologicals under Section510(j)(3) of the FD&C Act. Draft guidance was issued on notifications of a discontinuance or interruption in manufacturing under Section 506C of the FD&C Act. The agency also announced meetings of the Oncologic Drugs Advisory Committee and the Ophthalmic Devices Panel of the Medical Devices Advisory Committee. Read More
Petitioners seeking the use of “march-in” rights to obtain lower pricing on Astellas’s prostate cancer drug Xtandi (enzalutamide) may not have been successful in their appeal, but did obtain HHS recognition of the need to evaluate pricing in the use of march-in rights. Read More
Consistent open communication and complete public transparency is the only way to counteract scientific misinformation, which is a considerable threat to public health today, said Kimberlee Trzeciak, deputy chairman of FDA’s Office ofPolicy, Legislation, and International Affairs. Read More
When questioned by senators in a hearing Thursday about why Americans pay exponentially more for many brand name drugs than residents of other countries, pharmaceutical company CEOs repeatedly pointed to rebates they must offer to pharmacy benefit managers (PBM) as the real problem, an allegation the committee soundly rejected. Read More
The FTC’s supportive comment comes in response to the Biden Administration’s December call to invoke the Bayh-Dole Act of 1980’s “march-in” rights to control drug pricing. Read More