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Eisai’s Leqembi and AstraZeneca’s nirsevimab are both poised for a greenlight from the FDA if agency briefing documents prepared for two advisory committee meetings this week are any indication. Read More
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 in separate filings that Moderna and Pfizer reaped enormous profits using Promosome research. Read More
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 sterilization pilot. Read More
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 RWE in drug development. Read More
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. Read More
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 (GCP) guideline, ICH E6. Read More
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 CGMP area — process validation. Read More
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. Read More
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 CBER Director Peter Marks at the FDA Regulatory Education for Industry (REdI) Annual Conference on Monday. Read More
Twenty-five drugs manufactured by Intas Pharmaceuticals have been excluded from an FDA import alert because they are in short supply, the agency wrote in a June 2 import alert letter, banning, however, all other drugs manufactured at the company’s Sanand, India, facility. Read More