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Expanding on the clinical development of migraine drugs, the FDA has published a new draft guidance on development of drugs to prevent migraine to complement its current guidance on developing drugs to treat migraine. Read More
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 device. Read More
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. Read More
Maiden Biosciences received a Form 483 for quality system lapses after the FDA inspected the company’s Gaithersburg, Md., facility in November 2022. Read More
FDA investigators handed Novartis Farma SpA a Form 483 after finding documents missing information about equipment calibration, verification testing and software deviations. Read More
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. Read More
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 overcrowding of conference rooms as FDA staff return to on-site work. Read More
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 patient adverse reactions along with medication error reports and product quality complaints. Read More
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 improve the manufacturing process. Read More
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 recommendations and FDA's sterilization pilot. Read More
The FDA’s long-awaited draft guidance on decentralized trials (DCT) is finally out and industry experts say that while the guidance has done many things right, recommendations on how sponsors monitor remote locations, such as in patients’ homes, may draw industry pushback. Read More
Scientists have long been perceived and portrayed in film as old people in white lab coats perched at a bench full of bubbling fluorescent liquids. The present-day reality is quite different. Scientists are increasingly data jockeys in hoodies sitting before monitors analyzing enormous amounts of data. Modern day labs are more likely composed of sterile rows of robots doing the manual handling of materials, and lab notebooks are now electronic in massive data centers holding vast quantities of information. Today, scientific input comes from data pulled from the cloud, with algorithms fueling scientific discovery the way bunsen burners once did. Read More