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FDA Approves Abbott Test for Chagas Disease

[ Price : $8.95]

FDA approves Abbotts ESA Chagas [Trypanosoma cruzi (E. coli, recombinant) antigen], the first in vitro enzyme strip assay for use ...

OMB OKs Info on Dietary Ingredient Premarket Notification

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Federal Register Notice: The Office of Management and Budget approves a collection of information on premarket notification for a ...

Guidance on Medication Guides and REMS

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Federal Register Notice: FDA releases a guidance, Medication Guides Distribution Requirements and Inclusion in Risk Evaluation an...

FDA Warns Two Firms on Unapproved Eye Drug

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FDA sends Warning Letters to two manufacturers and distributors of unapproved fluorescein injection, a dye injected into the vein ...

FDA Sued for Generic Derma-Smoothe Approval

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Hill asks a federal court to order FDA to withdraw its approval of ANDAs for three generic Derma-Smoothe products.

FDA Finalizes Med Guide-only REMS Changes

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FDA finalizes a guidance that will allow the agency to circumvent heavy administrative burdens under its risk evaluation and minim...

Advisors Support Xifaxan Study Design

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Members of FDAs Gastrointestinal Drugs Advisory Committee say they support a Xifaxan clinical trial design developed by Salix and ...

First Drug for Equine Cushings Disease Approved

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FDA approves Boehringer Ingelheim Vetmedicas Prascend, the first drug to treat Cushings disease in horses.

Attorneys Want FDA Thalidomide Info

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Attorneys representing people who believe they suffered severe birth defects due to thalidomide sue FDA seeking agency archival in...

FDA Clears IntriCon Remote Cardiac Monitor

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FDA clears an IntriCon 510(k) for the Sirona Event and Holter Recorder, a second-generation cardiac diagnostic monitoring device.