FDA publishes a guidance with recommendations to assist companies that want to include child-resistant packaging statements in their drug product labe...
Ropes & Gray attorneys Kellie Combs and Sarah Blankstein say companies are not likely to get heavily involved in real-world evidence studies for regul...
FDA clears a SpineWelding 510(k) for its Elaris Pedicle Screw System, which is intended to provide immobilization and stabilization of spinal segments...
Federal Register notice: FDA announces an 11/7 public meeting entitled Promoting Effective Drug Development Programs: Opportunities and Priorities for...
Federal Register notice: FDA determines that Bayers Levitra (vardenafil hydrochloride) tablets, 2.5mg, were not withdrawn from sale for safety or effe...
FDA issues a warning against Miracle Mineral Solution because it is illegally promoted as a remedy for treating autism, cancer, HIV/AIDS, hepatitis an...
A group of U.S. Senate Democrats urge FDA acting commissioner Ned Sharpless to heavily punish AveXis for submitting manipulated data in its BLA for re...
FDA clears a Shimadzu Medical Systems 510(k) for the Fluorospeed X1 patient side conventional radiographic/fluoroscopic table system.