Cue Health’s over-the-counter molecular nucleic acid amplification test (NAAT) for COVID-19 has been granted FDA de novo authorization, making it the first traditionally authorized at-home test for any respiratory illness.…
Biotech firm Promosome is the latest company to sue big pharma for infringing on its patent for messenger RNA (mRNA) technology during the rush to develop a COVID-19 vaccine, claiming…
Upcoming events in the coming weeks include six FDA advisory committee meetings as well as webinars on subjects ranging from ICH E8 R1 recommendations, pharmaceutical quality risk management and FDA’s…
The FDA has selected the initial applications for participation in its Advancing Real-World Evidence (RWE) program, which allows pharmaceutical sponsors four meetings with the agency to discuss proposals to use…
Merck is suing the federal government over the landmark $740 billion Inflation Reduction Act (IRA), questioning the constitutionality of the nearly year-old law designed to lower drug costs. Source: Drug…
The FDA is seeking public comment from clinical trial sponsors, sites, investigators and other interested parties on a long-awaited revision of the International Council on Harmonisation’s (ICH) good clinical practice…
Compliance with current good manufacturing practice (CGMP) has always been a top enforcement priority for the FDA. And lately, the agency has been taking a tougher stance on one particular…
The use of FDA’s checklist-like cover letter attachments for controlled correspondence and generic drug submissions are voluntary, the agency emphasized in a final guidance released Monday. Source: Drug Industry Daily
A new FDA pilot program to quickly advance gene therapies for rare diseases will use several elements of the Operation Warp Speed medical product development program for COVID-19 products, said…
Novo Nordisk and BIOCORP have entered into negotiations for Novo Nordisk to acquire a controlling stake in BIOCORP, a French company which has been developing a Bluetooth enabled smart add-on…