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FDA publishes a guidance with recommendations to assist companies that want to include child-resistant packaging statements in the...[ Price : $8.95]
Ropes & Gray attorneys Kellie Combs and Sarah Blankstein say companies are not likely to get heavily involved in real-world eviden...[ Price : $8.95]
FDA clears a SpineWelding 510(k) for its Elaris Pedicle Screw System, which is intended to provide immobilization and stabilizatio...[ Price : $8.95]
A group of U.S. Senate Democrats urge FDA acting commissioner Ned Sharpless to heavily punish AveXis for submitting manipulated da...[ Price : $8.95]
FDA clears a Shimadzu Medical Systems 510(k) for the Fluorospeed X1 patient side conventional radiographic/fluoroscopic table syst...[ Price : $8.95]
Federal Register notice: FDA extends the comment period on a 7/9 notice about a public meeting alternative clinical trial approach...[ Price : $8.95]
Federal Register notice: FDA announces an 11/7 public meeting entitled Promoting Effective Drug Development Programs: Opportunitie...[ Price : $8.95]
Federal Register notice: FDA determines that Bayers Levitra (vardenafil hydrochloride) tablets, 2.5mg, were not withdrawn from sal...