Federal Register notice: FDA makes available a final guidance entitled Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for M...
FDA issues a safety alert on Alcons CyPass Micro-Stent, a small tube with tiny holes that is surgically implanted in the eye, due to its risk of eye d...
FDA announces steps to streamline its use of medical device third party reviewers.
FDA approves AstraZeneca Pharmaceuticals Lumoxiti (moxetumomab pasudotox-tdfk) injection for intravenous use for treating adult patients with relapsed...
Federal Register proposed rule: FDA proposes to amend current regulations to incorporate changes made to the Freedom of Information Act by recent laws...
Federal Register notice: FDA announces a 10/22 public advisory committee meeting of its Science Board. that will hear a response from CVM on recommend...
Pharm D Solutions recalls all sterile compounded drug products within expiry due to concerns that practices at the pharmacy have the potential to pose...
Federal Register proposed rule: FDA proposes to amend requirements for medical device premarket submissions to remove paper and multiple copies and re...