FDA Review posts the Federal Register notices for the week ending 7/27/2018.
FDA issues INSYS Therapeutics a complete response letter for its buprenorphine sublingual spray as a treatment for moderate-to-severe acute pain.
FDA clears a Cepheid 510(k) for the Xpert Xpress Flu/RSV test.
Federal Register notice: FDA makes available a draft guidance entitled Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition that...
Federal Register notice: FDA makes available a final guidance entitled Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpop...
FDA clears a LifeSignals 510(k) for its wireless LP1100 Life Signal Patch that is intended for enabling the next generation of wearable, healthcare mo...
Federal Register notice: FDA announces the fiscal year 2019 rates for generic drug program areas.
Federal Register notice: FDA releases a draft guidance entitled Peripheral Vascular Atherectomy Devices Premarket Notification [510(k)] Submissions....