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…

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…

Misuse of medical devices at home is the most pressing health technology safety hazard, says one of the nation’s largest nonprofit patient safety organizations. Source: Drug Industry Daily

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…

While consumers wanting the ability to fix products they’ve purchased came through with over 1,600 comments and strongly-worded frustrations supporting their “right to repair” their own possessions, the issue continues…

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 Draft guidance was issued on notifications of a discontinuance or…

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…

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…

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…

The FDA has issued a draft guidance on how and when applicants and manufacturers should provide information on interruptions or discontinuations of drugs, biological products and active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…