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FDA Vows Follow-up to Risky Devices Expos

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CDRH compliance director Tim Ulatowski says FDA is investigating reports of flagrant marketing of illegal and dangerous medical de...

Update on Antibiotics in Aquarium Fish

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Consulting editor John Scharmann updates information on the status of human-use antibiotics in home aquariums.

RLS Foundation Takes on Consumer Reports

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The Restless Leg Syndrome Foundation calls on its members and supporters to cancel subscriptions to Consumer Reports after the mag...

Learned Intermediary Rule Out in WV

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American Enterprise Institute fellow Ted Frank says there are many reasons why the West Virginia Supreme Court erred in throwing o...

CDRH Consensus Standard Guidances

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CDRH issues three guidances on using consensus standards to satisfy premarket review requirements.

FDA OKs Seroquel Expanded Use

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FDA approves an AstraZeneca supplemental NDA for Seroquel XR (quetiapine fumarate) and its expanded use as maintenance treatment i...

Gilead Science NDA for Cystic Fibrosis Patients

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Gilead Sciences submits an NDA for aztreonam lysine for inhalation (75 mg three times daily), an investigational therapy for treat...

GSK Intimidated Avandia Researcher: Grassley

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Sen. Chuck Grassley says GlaxoSmithKline tried to intimidate a university researcher who raised early questions about Avandia safe...

Gottlieb: FDA Unprepared for Follow-on Biologics

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Former FDA deputy commissioner for medical and scientific affairs Scott Gottlieb says organizational changes are needed at FDA to ...

FDA Seizes Dangerous Eyelash Cosmetic

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FDA orders the seizure of Jan Marini Skin Researchs Age Intervention Eyelash in San Jose as an unapproved and misbranded drug that...