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Upcoming events in the coming weeks include five FDA advisory committee meetings as well as webinars on subjects ranging from GxP system verification and FDA’s sterilization pilot. Read More
Specialized scientific liaisons will be key to moving rare disease drugs through the Accelerating Rare Disease Cures (ARC) Program, according to CDER Director Patrizia Cavazzoni. Read More
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 use of new data processing methods. Read More
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). Read More
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 serious type of recall as use of the device may cause serious injuries or death. Read More
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 some key steps in the process.Read More
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 requirements of limited government, property rights, the rule of law, and the separation of powers.” Read More
Futura Medical has been granted the first FDA OTC marketing authorization for its MED3000, a topical gel for the treatment of erectile dysfunction (ED). Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Read More
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 and 100 percent of U.S. pharmacies report being affected by drug shortage, CDER’s Office of Pharmaceutical Quality (OPQ) Director Mike Kopcha told FDAnews. Read More
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. Read More
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 study, showed that it conferred a significant clinical benefit to patients with mild cognitive impairment or early Alzheimer’s disease. Read More