FDA Issues Proposed Rule for OTC Antiseptics and Hand Soaps
U.S. regulators issued a proposed rule that would require makers of antibacterial hand soaps and body washes to demonstrate their products are safe and more effective than soap and water in preventing infection and the spread of bacteria.
New Bill Could Combat Superbugs by Fast-Tracking Antibiotics for FDA Approval
Late Thursday, House of Representatives members introduced the Antibiotic Development to Advance Patient Treatment Act of 2013 that would enable the FDA to approve antibiotic drugs for specific patient populations based on data from smaller clinical trials; Pharmaceutical trade group PhRMA comments on the proposed bill.
Bankrupt Savient Pharma Sells Assets to Crealta
Savient Pharmaceuticals Inc. plans to sell its drug portfolio, including the gout treatment Krystexxa, to Crealta Pharmaceuticals LLC for $120.4 million, pending bankruptcy court approval.