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FDA posts a draft guidance on Best Practices for Communication Between IND Sponsors and FDA During Drug Development.[ Price : $8.95]
FDA clears an ADC Therapeutics IND to begin clinical trials with ADCT-402, a novel antibody drug conjugate targeting CD19, a cell-...[ Price : $8.95]
FDA grants Trevena a fast track designation for oliceridine (TRV130) for managing moderate-to-severe acute pain.[ Price : $8.95]
FDA approves a Sun Pharmaceutical Industries ANDA for generic versions of Novartis chronic myeloid leukemia treatment Gleevec (ima...[ Price : $8.95]
An FDA safety alert says Lipo Escultura Corp. (Brooklyn, NY) is recalling all Lipo Escultura dietary supplement products because, ...[ Price : $8.95]
Qmed Daily says the number of CDRH medical device safety communications this year rose substantially over the numbers in 2014 and ...[ Price : $8.95]
Public Citizen calls on FDA to quickly finalize its proposed rule to allow generic drug manufacturers to update safety warnings wi...[ Price : $8.95]
FDA issues an updated final guidance on eCopy submission standards for medical devices.