The FDA released a Form 483 from a May 4-12 inspection conducted at Catalent’s Bloomington, Ind., facility pointing to continuing woes for the plant and its customers, with observations of…
Improving FDA advisory committee procedures and combatting misinformation are two important goals for FDA’s Chief Scientist Namandjé N. Bumpus who shared some insights from her first year of work during…
A new draft guidance focuses on obtaining tentative approval — granted for drugs that cannot be marketed in the U.S. because of existing patents or exclusivity — for various HIV…
Upcoming events in the coming weeks include six FDA advisory committee meetings, the GMP Quality Management vSummit and webinars from FDAnews, a WCG company on reliability assessment and medical device…
The FDA and the Drug Enforcement Agency (DEA) have asked manufacturers to confirm they are working to increase production of their allotted quota of ADHD drugs to help resolve shortages.…
Comments from numerous stakeholders have sounded the alarm over the lack of detail on oversight/responsibility for remote vendors and a new“task log” in the FDA’s draft guidance on decentralized trials…
The number of Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) applications and certificates in the European Union (EU) increased significantly in a recent six-month period, signaling some…
AstraZeneca announced that it will pay $510 million to settle patent infringement lawsuits with Bristol Myers Squibb (BMS) and Ono Pharmaceutical involving cancer treatments using PD-1 and CTLA-4 methods. Source:…
Risk management plans need to be continually updated as the design of a medical device or in vitro diagnostic evolves, said quality expert Dave Petrich in a July 19 webinar…
Baxter Healthcare’s recall of 23,000 infusion pumps due to repeat upstream occlusion false alarms has been deemed class I by the FDA, the most serious type of recall as use…