Listen to an audio podcast of the November 28, 2023, FDA Drug Safety Communication, FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR,…
The FDA has released two draft guidances with interim policies addressing the FDA’s efforts to finalize bulk drug lists for compounders subject to 503A regulations and for compounders using bulk…
As action dates for two groundbreaking sickle cell gene therapies loom, U.S. Senator Bill Cassidy, MD (R-LA), is raising questions about the cost, and how these extremely expensive, but life-changing,…
As the comment period closed Wednesday on a trio of FDA draft guidances covering data requirements for 510(k) device submissions, industry trade group AdvaMed expressed its clear concerns that the…
AbbVie and Cerevel Therapeutics announced that AbbVie will buy Cerevel Therapeutics and its neuroscience pipeline of schizophrenia, Parkinson's disease, and mood disorder drugs that are in multiple clinical and preclinical…
Medtronic notified EOFlow on Dec. 6 that it exercised its right to terminate its agreement to acquire the company based on multiple breaches, according to a Securities Exchange Commission Form…
Drug containers contaminated with wood, cellulose, brass and steel as well as multiple corrective and preventive actions (CAPA) to address mold are among the reasons the FDA listed in its…
The FDA has updated its eSTAR online medical device 510(k) application submission process — which became mandatory as of Oct. 1 — to include additional submission types. Source: Drug Industry…
Cordis’s recall of Infiniti angiographic catheters for lack of sterilization has been identified by the FDA as a Class I recall, the most serious type of recall as use of…
After agreeing to a voluntary plan to help lower drug prices in the UK, the Association of the British Pharmaceutical Industry (ABPI) has issued a statement today accusing the UK…