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Advanced Bionics Paying $12 Million Over False Claims

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Advanced Bionics agrees to pay more than $12 million to the federal government and participating Medicaid states to resolve a whis...

CGMP Deviations at Brazils Nortec Quimica

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FDA warns Brazils Nortec Quimica about CGMP deviations in its production of active pharmaceutical ingredients.

FDA States Plan B One-Step Does Not Cause an Abortion

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FDA revises the Plan B One-Step information sheet to clarify the emergency contraceptive cannot be used to cause an abortion of an...

Court Enters Consent Decree Against Oklahoma Compounder

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An Oklahoma federal court issues a consent decree against the Qualgen drug compounding facility and two of its principals.

M11 Clinical Electronic Structured Protocol

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FDA publishes an International Council for Harmonization guideline on a clinical electronic structured protocol.

FDA Pushing Naloxone OTC Switch: Attorney

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Attorney Heidi Gertner explains how FDA is pushing for a voluntary Rx to OTC switch of naloxone drug products.

Hypertension Labeling for Cardio Claims Guidance

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FDA publishes a guidance recommending that applicants change the labeling for antihypertensives to include standard language on th...

Drug Risks and Benefits in CSL Communications

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CDER Office of Prescription Drug Promotion researchers look for the most effective way to communicate risk information in characte...

Objectionable Conditions at Clinical Investigation Site

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FDA warns La Palma, CA-based Adarsh Daswani about issues in his work conducting a clinical investigation of an investigational dru...

Spending Bill Reverses Some FDA Court Losses: Attorneys

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Two Hyman, Phelps & McNamara attorneys say FDA succeeded in having Congress use the recent omnibus spending bill to allow it to ba...