Expanding on the clinical development of migraine drugs, the FDA has published a new draft guidance on development of drugs to prevent migraine to complement its current guidance on developing…

The FDA handed Sea-Long Medical Systems a warning letter on April 4 for failing to notify the agency of expanded indications for its treatment hood device. Source: Drug Industry Daily

FDA investigators handed Novartis Farma SpA a Form 483 after finding documents missing information about equipment calibration, verification testing and software deviations. Source: Drug Industry Daily

Maiden Biosciences received a Form 483 for quality system lapses after the FDA inspected the company’s Gaithersburg, Md., facility in November 2022. Source: Drug Industry Daily

A Form 483 cites Cocoa Beach, Fla.-based Ward Photonics for continuing problems with investigation and evaluation of customer complaints for possible medical device report (MDR) requirements. Source: Drug Industry Daily

Failure to resolve at least six of 10 observations from an earlier inspection resulted in another Form 483 in January for Theweb2u.com, maker of the Therapik insect bite and itch relief…

Face-to-face FDA meetings may have a hybrid component beginning June 12, focusing on “having only core participants with a primary speaking role in person while others join virtually” to avoid…

CDER’s Office of Surveillance and Epidemiology (OSE) 2022 Annual Report showed the total number of adverse event (AE) reports rose slightly from 2.23 million in 2021 to 2.34 million, capturing…

The FDA and the Medical Device Innovation Consortium (MDIC) are collaborating to offer funding of up to $300,000 to medical devicemakers that use advanced technologies to enhance product quality or…

Upcoming events in the coming weeks include six FDA advisory committee meetings as well as webinars and conferences on subjects ranging from advanced gene and cell therapy, ICH E8 R1…