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CDER posts a new manual of policies and procedures document for Critical Path Innovation Meetings.[ Price : $8.95]
Repros Therapeutics reports a meeting with FDA resulted in no additional study requirements to date for its anticipated low-testos...[ Price : $8.95]
CDRH policy analyst Abiy Desta says legacy 510(k)-cleared devices that are being modified and require a new 510(k) submission will...[ Price : $8.95]
Nellcor Puritan Bennett begins a Class 1 recall of its Puritan Bennett 980 Ventilator System due to a software error.[ Price : $8.95]
CDERs Office of Prescription Drug Promotion sends an untitled letter to Covis Pharmaceuticals over a physician letter promoting La...[ Price : $8.95]
FDA objects to an Amarin Pharmaceuticals promotional Rapid Overview Webcast Series - Print Invitation for Vascepa (icosapent ethy...[ Price : $8.95]
Novo Nordisk files an NDA with FDA for a 3 mg dose of liraglutide for chronic weight management.[ Price : $8.95]
A medical device product liability lawsuit overcomes a federal preemption defense by relying on a controversial Seventh Circuit Co...