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The FDA’s draft guidance on its Advanced Manufacturing Technologies (AMT) pathway would be restrictive to manufacturers in the cell and gene therapy spaces, the Alliance for Regenerative Medicine and the American Society of Gene and Cell Therapy said in filed comments. 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
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
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The FDA has issued a draft guidance on how and when applicants and manufacturers should provide information on interruptions or discontinuations of drugs, biological products and active pharmaceutical ingredients to help the agency prevent or mitigate shortages. Read More
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has proposed waiving certain requirements for biosimilars on “solid” evidence of quality comparability. Read More
Vanda Pharmaceuticals is once again suing HHS and the FDA, claiming that the agencies are using regulatory process to accomplish an “end run” around the timetable required by law in its efforts to obtain an approval or a hearing for a new indication for its drug Hetlioz (tasimelteon) as a treatment for insomnia. Read More