Alvotech has drawn an FDA Complete Response Letter (CRL) for manufacturing facility deficiencies in its BLA for AVT02, a biosimilar candidate for AbbVie’s mega-blockbuster anti-inflammatory therapy Humira (adalimumab). Source: Drug…
There are several “green” pathways to help expedite overseas medical device and in vitro diagnostics (IVD) approval in China — including the innovation, priority and emergency use pathways, as well…
A joint FDA advisory committee has cleared the way for Otsuka and Lundbeck’s Rexulti (brexpiprazole) as a new treatment for dementia-related agitation. Source: Drug Industry Daily
The FDA’s Office of Regulatory Affairs (ORA) needs technological advances to create “one source of truth” rather than the siloed data systems that currently hamper its efforts to modernize inspectional…
New final guidances from the International Medical Device Regulators Forum (IMDRF) explain how to identify and address cybersecurity risks in older devices containing software and offer advice on large-scale manufacturing…
Over the past week, the FDA issued two final and three draft guidances, as well as requests for comments on several advisory committee meetings, user fees, IND applications and the…
Over the past week, the FDA issued two final and three draft guidances, as well as requests for comments on several advisory committee meetings, user fees, IND applications and the…
CDER’s Office of New Drugs (OND) Director Peter Stein is a nationally recognized leader in pharmaceutical research and development. Before joining the FDA in 2016 as OND deputy director he…
The White House said Thursday that it will ask the U.S. Supreme Court to step in to defend the FDA’s 22-year-old decision to approve the abortion drug mifepristone after an…
Bristol Myers Squibb (BMS) and Pfizer have together filed separate lawsuits against two generic drugmakers, seeking to prevent the release of generic versions of Eliquis (apixaban), the blockbuster anticoagulant the…