Medical Device Manufacturers Association says it would be wasteful and duplicative to use medical device user fee funds to advance real-world data/evi...
FDA issues a clinical hold against Athenex and Baylor College of Medicines kUR-501 after the death of a young heavily pretreated male patient.
Former CDRH Office of Compliance director Steven Silverman recommends device manufacturers look at FDAs remote regulatory assessment program as a temp...
FDA reviewers appear open to considering accelerated approval for Biogens amyotrophic lateral sclerosis drug tofersen in patients with the superoxide ...
Federal Register notice: FDA makes available a draft guidance entitled Electronic Systems, Electronic Records, and Electronic Signatures in Clinical I...
FDA accepts for review an Ipsen resubmitted NDA for palovarotene as a potential treatment for fibrodysplasia ossificans progressive.
FDA tells Sarepta Therapeutics that it has decided to hold an advisory committee meeting to review its gene therapy BLA for SRP-9001 (delandistrogene ...
FDA posts a draft guidance entitled Pharmacogenomic Data Submissions that discusses the use of such data in drug development.
