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FDA, Alliance Launch Lupus ABC

[ Price : $8.95]

FDA joins with the Lupus Research Alliance to launch a collaborative Lupus Accelerated Breakthrough Consortium to improve lupus cl...

Emergent Bio Gains OTC Approval of Narcan Spray

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FDA approves Emergent BioSolutions Narcan 4 mg naloxone hydrochloride nasal spray, the first nonprescription over-the-counter prod...

Janssen Scraps RSV Vaccine Development

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Janssen Pharmaceutical discontinues the development of an investigational respiratory syncytial virus adult vaccine and related Ph...

CDRH Testing Communications Info Collection

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Federal Register notice: FDA sends to OMB an information collection extension entitled Testing Communications by FDAs Center for D...

FDA Shifting Accelerated Approval Approach: Attorneys

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Two Ropes & Gray attorneys see signs that FDA may be shifting its approach to drug accelerated approvals.

Non-Spinal Orthopedic Plate 510(k) Guidance

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FDA publishes a draft guidance with recommendations for 510(k) submissions for orthopedic non-spinal bone plate, screw, and washer...

Court Orders Release of FDA Vanda Info

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The DC federal court orders FDA to give Vanda Pharmaceuticals information from its review of a Vanda sNDA for a new Hetlioz indica...

IND Not Submitted for Cornea Associates Trials: FDA

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FDA warns Dallas, TX-based Cornea Associates about conducting clinical investigations without submitting a required IND.

Merck Touts New Keytruda Endometrial Cancer Data

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Merck says it will meet with regulatory authorities about an expanded indication after reporting Phase 3 trial results of Keytruda...

House Committee Questions FDA Drug Shortage Actions

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The leadership of the House Energy and Commerce Committee and two of its subcommittees asks FDA for detailed drug shortage informa...