FDA posts for comment a draft document with best practices for agency staff in conducting postmarket safety surveillance of drugs and biologics.
The Senate Health, Education, Labor & Pensions Committee schedules an 11/20 confirmation hearing for FDA commissioner nominee Stephen Hahn.
FDA approves Sandozs Ziextenzo (pegfilgrastim-bmez), a biosimilar to Amgens Neulasta (pegfilgrastim).
FDA clears a 270Surgical Ltd. 510(k) for its SurroundScope System, which the company describes as the first laparoscopic camera system to offer up to ...
Public Citizen petitions FDA and the Drug Enforcement Administration to up-classify Tramadol and similar drugs from Schedule 4 to Schedule 2 under the...
CBER issues a SOPP on regulatory meetings under some user fee programs.
GlaxoSmithKline asks FDA to look at four categories of information that have been raised in litigation over Zofran pregnancy labeling and determine wh...
FDA clears a Vyaire Medical 510(k) for the bellavista 1000e ventilator.