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As part of the FDA’s effort to increase access to home-use medical devices, CDRH is seeking comments from devicemakers, researchers, clinicians and the public on how to bring healthcare directly to patients wherever they are — at home, at work, in cities or in rural communities. Read More
The FDA published multiple guidances on Friday to help sponsors conduct drug-drug interaction studies for therapeutic proteins, develop drugs for treating bladder pain syndrome, nonclinical evaluation of drug immunotoxic potential and request feedback from agency officials on device submissions under the Q-Submission program. Read More
Medical device manufacturers should prepare now for the potential disruption in fluctuating power, contaminants or unusual levels of heat or humidity that often occur during hurricane season, the FDA advises. Read More
Over the past week, the FDA issued a proposed rule on Medication Guides and draft guidance on developing drugs for preventive treatment of migraines. 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
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
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