We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Manufacturers receiving a heparin sodium drug substance or API represented as “USP” for use in a combination product should document that the substance has been tested according to the current USP drug substance monograph, the agency said. Read More
The agency plans on working with the International Medical Device Regulators Forum on a standard format to support electronic device submissions. Read More
FDA Commissioner Scott Gottlieb said the third-party reviews “must be equivalent in rigor and completeness to the kinds of reviews that we’d conduct.” Read More
AdvaMed asked the FDA to give more examples of combination product types and manufacturing processes for which good manufacturing practices diverge from standard combination product CGMPs. Read More
The “Smart” template the agency used to guide submission reviews — at the time of the OIG’s study — didn’t include any cybersecurity questions. Read More
Gottlieb said regulatory agencies and policymakers should take a consistent approach for all in vitro clinical tests regardless of whether they are developed by a traditional manufacturer or a clinical laboratory. Read More
FDA Commissioner Scott Gottlieb and CDRH Director Jeff Shuren hailed the “reimagination” of health care delivery through mobile medical apps and cited steps the agency is taking to encourage innovations in the rapidly developing market. Read More
India’s Central Drugs Standard Control Organization is calling on Johnson & Johnson to compensate patients who suffered serious adverse events linked to the company’s ASR hip implants. Read More