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OPDP Says Investigational Remoxy Promoted on Web

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CDERs Office of Prescription Drug Promotion says Durect and Pain Therapeutics are illegally promoting Remoxy ER while it is still ...

Limits of Device Preemption Described

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Attorney Cliff Rieders looks at cases in which state tort claims against medical device manufacturers were not preempted by federa...

FDA Import Operation Chief Leaves FDA for Law Firm

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After a 24-year career, FDA Division of Import Operations director Domenic J. Veneziano leaves the agency to join international tr...

Petition Seeks Ban on Antibiotics in Livestock/Poultry

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Several public health groups petition FDA asking that it withdraw approval of the use of medically important antibiotics in livest...

WLF Wants Court Jurisdiction Decision Tossed

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Washington Legal Foundation asks a federal appeals court to overturn a lower court ruling allowing out-of-state plaintiffs to sue ...

Array Gains SPA for Colon Cancer Therapy

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Array BioPharma reaches agreement with FDA on a special protocol assessment related to BEACON CRC, a global Phase 3 trial involvin...

How FDA Calls Some Old Drugs New

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Pepper Hamilton attorneys trace the evolution of FDA thinking on when a previously-approved compound could still receive NCE exclu...

ICH Toxicokinetics Microsampling Draft Guidance Published

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FDA publishes an International Council on Harmonization draft guidance on microsampling in toxicokinetic animal studies.

CDRH Denies Petition Seeking 510(k) Exemption

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CDRH denies a Germaine Laboratories petition that sought an exemption from premarket notification requirements for method, metalli...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites American Pharmacy of Illinois, Central Illinois Compounding, Harrington House, K...