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FDA Clears Bovie Medical PlazXact Surgical Ablator

[ Price : $8.95]

FDA clears a Bovie Medical 510(k) for its PlazXact bipolar ablator, a surgical tool designed to improve a surgeons precision and s...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites A.R.C.O.S. Srl , Aussimed, Bedfont Scientific, Beyond Technology, Centro Naturis...

Panel Backs Seeker Newborn Lysosomal Screener

[ Price : $8.95]

FDAs Clinical Chemistry and Toxicology Devices Panel of the Medical Devices Advisory Committee unanimously votes to recommend that...

Orphan Drug Status for Tivorsan Duchenne Drug

[ Price : $8.95]

FDA grants Tivorsan Pharmaceuticals an orphan drug designation for TVN-102 (biglycan) and its use in treating Duchenne Muscular Dy...

FDA Sends Info on Patent Claims to OMB

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Federal Register Notice: FDA submits a proposed collection of information on patent submission and listing requirements and 30-mon...

Helsinn, MEI Pharma Agree to Develop Leukemia Drug

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Helsinn and MEI Pharma enter into a licensing, development and commercialization agreement for pracinostat, a Phase 3-ready drug c...

Guidance on 510(k)s for Electrosurgical Devices

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Federal Register Notice: FDA releases a guidance: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for Gene...

CDER Policy on Gelatin Capsule Shell Supplier Changes

[ Price : $8.95]

CDER has posted a new internal policy on drug sponsors who seek approval for a Change in Hard Gelatin Capsule Shell Supplier.

FDA Launches New Online Orange Book

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FDA launches an new online Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).