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…

Upcoming events in the coming weeks and months include two FDA advisory committee meetings; MAGI 2024: The Clinical Research Conference; and webinars on overcoming common clinical trial challenges, supplier quality…

In 2022, FDA inspections of both foreign and domestic drug manufacturing plants were still far below pre-COVID-19 pandemic levels, although the number of citations soared, a new study has found.…

After agreeing this fall to participate in the Inflation Reduction Act (IRA) drug price negotiation program, AstraZeneca — whose type 2 diabetes therapy Farxiga (dapagliflozin) was among the first 10…

In this edition of Quick Notes, we look at expanded clearance for a smart watch, a retinal camera with designs on uncovering health problems, new software to better track neurological…

The House Subcommittee on Health Care and Financial Services has asked the FDA to schedule a briefing with Committee staff no later than Dec. 11 to help with an investigation…

Aggressively using all the FDA’s regulatory flexibility to advance burgeoning treatments for rare diseases, particularly gene therapy, was a theme highlighted Monday by CBER Director Peter Marks. Source: Drug Industry…