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Sens. Warren, Murray, and Smith raise 18 additional questions for FDA to answer on its software pre-certification program.[ Price : $8.95]
FDA issues a draft guidance on changes affecting its implementation of GDUFA 2 user fees.[ Price : $8.95]
FDA accepts for review a Genentech BLA for satralizumab for treating adults and adolescents with neuromyelitis optica spectrum dis...[ Price : $8.95]
FDA publishes a draft guidance to assist sponsors develop drugs to treat hepatitis D virus infection.[ Price : $8.95]
Federal Register notice: FDA announces an 11/21 public meeting entitled Office of Minority Health and Health Equity Public Meeting...[ Price : $8.95]
FDA lists six of its 2019 activities to promote medical device cybersecurity safety and awareness.[ Price : $8.95]
FDA grants Shreis Scalene Sciences a Breakthrough Device designation for Cytotron, a whole-body therapeutic medical device for use...[ Price : $8.95]
FDA grants Recro Pharmas appeal of an agency complete response letter for the firms IV meloxicam.