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 ...
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FDA posts a draft guidance entitled Pharmacogenomic Data Submissions that discusses the use of such data in drug development.
Federal Register notice: CDER announces the continuation of its Regulatory Project Management Site Tours and Regulatory Interaction Program.
FDA issues Olympus Medical Systems a Warning Letter after inspecting the firms Tokyo facility and documenting GMP deficiencies.
A federal judge approves a $25 million class action settlement involving Johnson & Johnsons Remicade (infliximab).
CDER posts its Office of Compliance Annual Report for fiscal year 2022.
