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FDA issues a draft guidance outlining a proposed compliance policy that could ease certain premarket requirements for respirators ...[ Price : $8.95]
FDA has granted Opna Bio a fast track designation for its investigational therapy OPN-6602 and its use in treating patients with r...[ Price : $8.95]
U.S. Sen. Susan Collins (R-ME) uses a Senate hearing 4/16 to spotlight barriers to lower-cost drugs, pressing an expert witness on...[ Price : $8.95]
FDA satellite laboratories branch director JaCinta Batson touts the value of the laboratories work in international mail facilitie...[ Price : $8.95]
FDA classifies a correction involving certain ventilators manufactured by Philips as a Class I recall, warning that continued use ...[ Price : $8.95]
FDA seeks expansion of testosterone replacement therapy use, encouraging drugmakers to explore whether existing products could be ...[ Price : $8.95]
An Institute for Clinical and Economic Review white paper states the potential benefits and challenges of several policy changes t...[ Price : $8.95]
AdvaMed says it supports FDA efforts to expand exemptions from premarket notification for some Class 2 devices.