FDA issues a draft guidance on Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and C...
Becton Dickinson recalls its BD Vacutainer Blood Collection Tubes with lavender, tan, pink and green rubber tube stoppers due to a chemical in the sto...
Federal Register notice: FDA announces a 5/2 Antimicrobial Drugs Advisory Committee meeting on an Achaogen NDA for plazomicin.
FDA clears an Auris Health 510(k) for the Monarch Platform to assist with diagnostic and therapeutic bronchoscopic procedures for treating lung cancer...
FDA clears a Delta Med 510(k) for the DeltaVen Closed System Catheter.
AbbVie decides to not seek accelerated approval for Rova-T (rovalpituzumab tesirine) as a third-line treatment for relapsed/refractory small cell lung...
Federal Register notice: FDA announces a 6/25-26 public symposium entitled 2018 Center for Biologics Evaluation and Research Science Symposium.
Federal Register notice: FDA announces OMB approval of several information collections.