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Congressional FDA Oversight Intimidating Staffers

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FDA deputy commissioner Janet Woodcock says FDA staff morale is suffering under the onslaught of congressional safety probes.

Two Arrested for Diverting Rx Drugs

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Officials charge a Wyeth representative and a community pharmacy owner with selling illegally diverted drugs.

Revised Boxed Warning Ordered for Avandia

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FDA orders a revised boxed warning on GlaxoSmithKlines diabetes drug Avandia (rosiglitazone) over its potential increased risk for...

Address Change for Idexx

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Federal Register Final rule: FDA amends its animal drug regulations to change the sponsor address for Idexx Pharmaceuticals.

FDA OKs Fort Dodge Labeling Revisions

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Federal Register Final rule: FDA approves a Fort Dodge Animal Health sNADA for label revisions for chlortetracycline soluble powde...

King to Stop Making Procanbid

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King Pharmaceuticals tells FDA that it will stop making its anti-arrhythmic Procanbid (procainamide hydrochloride extended-release...

FDA Wants More Info on Synvisc PMA

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FDA requests additional analyses and data from Genzyme Corp. for its PMA for Synvisc-One (hylan G-F 20).

Quality Problems at Troy Innovative Instruments

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FDAs Cincinnati District Office warns Troy Innovative Instruments on Quality System violations in its manufacturing facility.

FDA Faulted for Allowing Human Antibiotics in Aquariums

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Consulting editor John Scharmann challenges FDAs approval of human-use antibiotic dosage forms for 9 million home aquariums and su...

Detailing Changing at Pittsburgh Hospital

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The University of Pittsburgh Medical Center is finalizing a new conflict-of-interest code severely restricting industry access to ...