An extended-release (ER) generic lamotrigine, used to treat epilepsy, is bioequivalent to GSK’s Lamictal, the FDA has determined — a finding that opens the way for pharmacy-level substitution of any…

CDRH is accepting and holding in-person meetings with stakeholders and also offering hybrid in-person and virtual – meeting options, Director Jeff Shuren said in a statement Wednesday updating the industry…

LXR Biotech received a warning letter from the FDA for having methods, facilities, controls for manufacturing, processing or holding its drug product that do not conform to GMPs, after the…

Quidel Cardiovascular’s recall of Quidel Triage Cardiac Panels, used to diagnose a heart attack, has been deemed class I by the FDA, the most serious type of recall as use…

The FDA slapped Iso-Tex with a Form 483 following a Jan. 30 – Feb. 10 inspection because the radiopharmaceutical manufacturer failed to prevent microbiological contamination of drug products at its…

Stryker received an FDA Form 483 after a Jan. 17-24 inspection of its Portage, Mo., plant showed that the company did not have a formal unit to receive, review and…

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A new draft guidance focuses on obtaining tentative approval — granted for drugs that cannot be marketed in the U.S. because of existing patents or exclusivity — for various HIV…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…