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FDA joins with the Lupus Research Alliance to launch a collaborative Lupus Accelerated Breakthrough Consortium to improve lupus cl...[ Price : $8.95]
FDA approves Emergent BioSolutions Narcan 4 mg naloxone hydrochloride nasal spray, the first nonprescription over-the-counter prod...[ Price : $8.95]
Janssen Pharmaceutical discontinues the development of an investigational respiratory syncytial virus adult vaccine and related Ph...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled Testing Communications by FDAs Center for D...[ Price : $8.95]
Two Ropes & Gray attorneys see signs that FDA may be shifting its approach to drug accelerated approvals.[ Price : $8.95]
FDA publishes a draft guidance with recommendations for 510(k) submissions for orthopedic non-spinal bone plate, screw, and washer...[ Price : $8.95]
The DC federal court orders FDA to give Vanda Pharmaceuticals information from its review of a Vanda sNDA for a new Hetlioz indica...[ Price : $8.95]
FDA warns Dallas, TX-based Cornea Associates about conducting clinical investigations without submitting a required IND.