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FDA Hears BTC Drug Support, Opposition

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Stakeholders tell FDA there are good and bad reasons to sell additional drugs from behind the counter.

Celebrities Push Flu Vaccinations

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Actress Jennifer Garner and other celebrities push flu vaccination in a Sanofi-Pasteur-funded American Lung Association awareness ...

Amgen Cooperating with Subpoenas

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Amgen says it will cooperate in responding to subpoenas seeking records on unidentified products issued by two U.S. Attorneys.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites ProBed Medical Technologies and Troy Innovative Instruments.

FDAs Foreign Model Could be Good for Domestic Inspections

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Consulting editor John Scharmann compares the management of FDAs foreign and domestic inspections and concludes that the foreign r...

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 ...