An FDA final guidance on premarket submissions for device software functions recommends a risk-based approach to help determine whether the sponsor should submit basic or enhanced documentation to explain its…

FDA’s method for assessing requests for major-to-minor reclassifications for complete response (CR) letters is described in the just-released Manual of Policies and Procedures (MAPP). Source: Drug Industry Daily

The recall of Walnut Wearable smart thermometer, a device that continuously monitors body temperature of infants and children up to 6 years, is now deemed FDA Class I, the most…

When preparing for meetings with regulators, it is essential that you view them as partners in the drug development process. Mark Lane, Adair Turner and Patrick Larcier of PharmaLex outline…

Several chambers of commerce have sued HHS and CMS over the Inflation Reduction Act (IRA) claiming that the prescription drug price control program is “a violation of America’s fundamental constitutional…

Futura Medical has been granted the first FDA OTC marketing authorization for its MED3000, a topical gel for the treatment of erectile dysfunction (ED). Source: Drug Industry Daily

As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Source: Drug Industry Daily

The federal government is tackling the issue of drug shortages from all sides, but the shortages continue to grow. Eighty percent of physicians report having patients affected by drug shortage…

Novartis will pay up to $3.5 billion for Chinook Therapeutics for its pipeline of two high-value late-stage medicines for the treatment of rare, severe chronic kidney disease. Source: Drug Industry…

Eisai’s antiamyloid antibody Leqembi (lecanemab) got a unanimous 6-0 thumbs-up from members of the FDA’s Central and Peripheral Nervous Systems Drugs Advisory Committee, who agreed that CLARITY-AD, the drug’s confirmatory…