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Warning Added on Hep C Drugs about Hep B Infections

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FDA warns patients and healthcare providers about the risk of hepatitis B virus becoming an active infection again in any patient ...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Bellus Medical, Collagen Matrix and Navinta.

FDA OKs St. Jude Medical BurstDR for Pain Relief

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FDA approves a St. Jude Medical PMA for the BurstDR stimulation, a physician-designed spinal cord stimulation (SCS) for treating c...

FDA Withdraws 44 NDAs, 158 ANDAs

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Federal Register Notice: FDA annouces the withdrawal of 44 NDAs and 158 ANDAs from multiple applicants because the drug products a...

Petition Denial on 510(k) Exemption for Reagent Tablet

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Federal Register Final Order: FDA publishes an order denying a petition requesting exemption from the premarket notification requi...

Info Collection Extension on CVM e-Submission Guidance

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Federal Register Notice: FDA announces an information collection request extension related to a CVM guidance on How to Submit Info...

Comments Extended for Dietary Supplements Guidance

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Federal Register Notice: FDA extends the comment period for a revised draft guidance on Dietary Supplements: New Dietary Ingredien...

Workshop to Hear Veteran Amputee Input on Prosthetics

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Federal Register Notice: FDA announces a public workshop entitled Center for Devices and Radiological Health Veteran Amputee Devic...

Enter Data First to Database: Lilly Exec

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Lillys Mark Newton says drug companies should change their data entry layering design to protect data integrity.

Court Upholds FDA Freedom of Information Procedures

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Attorney Jenifer Stach says the Connecticut federal court upheld FDAs procedures for dealing with requests for expedited processin...