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FDA Wrist Slap for HIV Clinical Investigator

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A mild consent decree between the agency and prominent HIV clinical investigator Daniel Berger signals a softer side from the age...

Group Says Government Workers Believe Agencies Too Close to Business

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The Union of Concerned Scientists says it was told by FDA and USDA field workers that business and political interference in food ...

FDA Safety Reviewers Charge Bias with Avandia Panel Members

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Two FDA drug safety reviewers say the agency stacked the deck with biased panel members at a recent advisory committee meeting tha...

Advisors Asked to Comment on Meridia Withdrawal

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FDA asks its Endorcrinologic and Metabolic Drugs Advisory Committee whether it believes there are steps that can be taken to adequ...

FDA Withdraws 5 NDAs

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Federal Register Notice: FDA withdraws approvals of five NDAs because the applicant holders have repeatedly failed to file require...

FDA Approves Falsodex 500 mg Dose

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FDA approves a 500 mg dose of AstraZenecas Falsodex for treating some breast cancer patients.

'Revolving Door Lobbyist' Named as FDA's New 'Top Cop'

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FDA selects HHS associate deputy assistant secretary for health policy and former Arnold & Porter partner Dara Corrigan, who has b...

FDA 'Fast Track' for Palsy Drug

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FDA grants a fast track designation for Noscira's neuroprotector drug NP-12 (tideglusib) for treating Progressive Supranuclear Pal...

K-V Pharmaceutical Passes FDA Facility Inspection

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FDA allows K-V Pharmaceutical to resume marketing its first product under a consent decree potassium chloride.

Review Period Set for Saphris

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Federal Register Notice: FDA determines the regulatory review period for NV Organons Saphris for the purpose of patent extension.