After 10 Years, US FDA ‘Additional Conditions’ Proposed Rule Offers ‘Novel Switch’ Pathway
Publication of "ACNU" proposed rule wasn’t reached in straight line and featured coining another term with more of a regulatory sound, “NSURE,” and detours on explaining where the agency wouldn’t steer OTC drug manufacturing and marketing.
You may also be interested in...
Approved through De Novo regulatory pathway used to classify novel medical devices for which there is no legally marketed predicate product, Eroxon, packaged in single-use tubes, gives Futura first entry to US market for OTC therapeutic products approved with ED indication.
“We want to make sure digital is embedded into every aspect of our business, from R&D and supply chain, to marketing and finance,” says Johnson & Johnson's president of global self-care and consumer experience organization Manoj Raghunandanan in this exclusive interview.
Agency publishes Prescription Drug User Fee Act rates for FY2023, the first of five covered in reauthorization of program Congress approved on 30 September as legislation added to a continuing resolution to fund federal agencies through 16 December.