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Proposed FDA Advertising Research Often Unneeded: PhRMA

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PhRMA questions whether FDA is trying to carry out too much research into drug advertising and promotion without having a clear, o...

Amneal Recalls 13 Lorazepam Lots Over Dose Dropper

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Amneal Pharmaceuticals recalls 13 lots of lorazepam oral concentrate, USP 2mg/mL, due to a defect in the dropper markings.

Approval Withdrawn on Upsher-Smiths ANDA for Zaleplon

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Federal Register notice: FDA withdraws approval of an Upsher-Smith Laboratories ANDA for zaleplon (reference product: Sonata) caps...

Cook Medical Recalls Zenith Endovascular Graft

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Cook Medical recalls its Zenith Alpha Thoracic Endovascular Graft when used for treating blunt traumatic aortic injury because blo...

Califf Wants Sweeping Overhaul of Clinical Trial System

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Former FDA commissioner Robert Califf calls for a federated system generating fundamental data needed for a new approach to balanc...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Foshan Flying Medical Products Co. and Homeolab USA.

FDA OKs MobiusHD CALM 2 Trial

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FDA approves Vascular Dynamics IDE application for the CALM 2 pivotal trial of its MobiusHD system to treat resistant hypertension...

BioStable Aortic Annuloplasty Device Cleared

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FDA clears a BioStable Science & Engineering 510(k) for the HAART 200 Aortic Annuloplasty Device, an annuloplasty device designed ...

Transcript Posted on FDA Hatch-Waxman Amendments

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FDA posts a transcript of a 7/19 public meeting on Hatch-Waxman Amendments and its discussion on whether an appropriate balance is...

FDA Accepts Portola Pharmaceuticals BLA Resubmission

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FDA accepts for review a Portola Pharmaceuticals BLA resubmission for AndexXa (andexanet alfa) and its use as a universal reversal...