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Guidance on Flow Cytometric Devices

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance: Flow Cytometric Devices to address review concerns about the devices used ...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

FDA Accepts Pfizer NDA for Breast Cancer Drug

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FDA accepts for priority review a Pfizer NDA for palbociclib, intended for use in combination with letrozole as a first-line treat...

FDA Approves VisionCare Telescope for Younger AMD Patients

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FDA approves a VisionCare Ophthalmic Technologies PMA for its Implantable Miniature Telescope for use in patients living with bila...

Quidel 510(k) for Adenovirus Assay Cleared

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FDA clears a Quidel Corp. 510(k) to market its Lyra Adenovirus Assay, a real-time polymerase chain reaction test for the qualitati...

Orexo Files sNDA for Zubsolv

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Orexo AB files a supplemental NDA for Zubsolv (buprenorphine/naloxone sublingual tablet) to expand the labeled indication to inclu...