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FDA Clears Clinical Innovations Uterine Contraction Monitor

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FDA clears a Clinical Innovations (Salt Lake City) 510(k) for its Koala Toco, a tocodynamometer that is designed to utilize air-ch...

FDA Not Supporting Boxed Warning Removal for Chantix

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FDA says it wants data from an upcoming trial before it can consider removing a boxed warning on Pfizers smoking cessation drug Ch...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Alpha Medical Instruments, Beacon Hill Medical Pharmacy, Beijing Shunxin Meihua ...

FDA Sends Collection of Info on Exports to OMB

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Federal Register Notice: FDA submits a proposed collection of information on notification and recordkeeping requirements for expor...

Guidance on Flow Cytometric Devices

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Federal Register Notice: FDA releases a draft guidance: Flow Cytometric Devices to address review concerns about the devices used ...

FDA Plans Clinical Research Conference

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Federal Register Notice: FDA and the Society of Clinical Research Associates plan an educational conference 11/5-6 on the agencys ...

Court Orders Destruction of Unapproved Ascend Labs Drugs

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An Ohio federal judge orders the destruction of nearly 2,000 cases of FDA-unapproved hydrocortisone acetate and other drugs made b...

HealthCore in Five-year Sentinel Contract

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HealthCore says it has entered into a new five-year agreement with Harvard Pilgrim Health Care Institute as part of the FDA Sentin...

Whistleblowers Sue AZ in Texas Over Seroquel

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Two whistleblowers and the State of Texas sue AstraZeneca alleging illegal marketing of its atypical antipsychotic drugs Seroquel ...

Pharmacist Group Wants Viagra in Behind-the-counter Status

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Pharmacist Planning Service petitions FDA to add Pfizers erectile dysfunction drug Viagra (sildenafil) to behind the pharmacy coun...