The FDA granted expedited review to Humacyte’s tissue therapy under the new Regenerative Medicine Advanced Therapy pathway — one of the first products to receive the designation established by the…
The FDA said it will delay its “intended use” rule governing when tobacco products are to be classified as drugs, devices or combination products. Source: Drug Industry Daily
Four former FDA commissioners have called on Congress to abandon proposals that would allow drug imports, warning that such measures would come with substantial risks and only have a small…
Valeant’s Dow Pharmaceuticals filed a lawsuit against Teva’s Actavis, alleging infringement of two patents on the acne drug Onexton. Source: Drug Industry Daily
The EU Court of Justice has denied the European Medicines Agency appeals to allow the agency to release documents as part of its transparency efforts. Source: Drug Industry Daily
Pharmaceutical companies and clinical research organizations are seeking greater clarity in an FDA draft guidance covering clinical trials with multiple endpoints. Source: Drug Industry Daily
President Trump released his first budget blueprint yesterday, calling for FDA user fees to rise to more than $2 billion for fiscal 2018 — up from the $1.36 billion set…
Two lawmakers have asked the FDA to explain why the agency approved Marathon’s application to market the old drug Emflaza (deflazacort) as a new treatment for Duchenne muscular dystrophy. Source:…
Dietary supplement firm Cape Fear Naturals landed a warning letter from the FDA over misbranding of products and GMP issues. Source: Drug Industry Daily
The Association of the British Pharmaceutical Industry found four drugmakers — Celgene, Takeda, Vifor Pharma and Pierre Fabre — violated the group’s code of practice by engaging in activities ranging…