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Federal Register notice: FDA makes available a draft guidance entitled Notification of a Permanent Discontinuance or Interruption ...[ Price : $8.95]
FDA commissioner Robert Califf and chief scientist Namandj Bumpus withdraw Covis Pharmas preterm birth drug Makena and its generic...[ Price : $8.95]
FDA clears a restor3d 510(k) for the Axiom PSR System for use with the companys Kinos Axiom Total Ankle System.[ Price : $8.95]
The Justice Department says two Texas men face up to five years in prison after pleading guilty to selling misbranded drugs over t...[ Price : $8.95]
Federal Register notice: FDA announces the availability of a draft guidance entitled Human User Safety (HUS) in New and Abbreviate...[ Price : $8.95]
FDA publishes the last in a series of four guidances on aspects of patient-focused drug development.[ Price : $8.95]
The Justice Department charges three former top officials at Magellan Diagnostics over their role in allegedly concealing a device...[ Price : $8.95]
FDA warns Somerset, NJ-based Aspire Pharmaceuticals about multiple violations in its production of dietary supplements and human d...