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The FDA will not let Intarcia choose reviewers for the upcoming Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting to consider the company’s troubled diabetes drug-device product, nor will the agency grant other requests Intarcia made last month. Read More
New FDA drug approvals in May include the first vaccine for respiratory syncytial virus, a hot flash treatment for menopausal women, a gene therapy for a rare skin disease and the first and only treatment for a rare hematologic disorder. Additionally, the FDA approved a next-generation sequencing-based companion diagnostic test for solid tumor profiling. Read More
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
iRhythm Technologies’ mislabeling of a cardiac monitor and its component software as well as failure to report serious adverse events, including two deaths, netted the devicemaker an FDA warning in late May. Read More
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. 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