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Similasan Marketing Unapproved New Drugs: FDA

[ Price : $8.95]

FDA warns Switzerlands Similasan AG that it is marketing unapproved new ophthalmic drugs that are manufactured with significant CG...

FDA Warns 8 Firms for Unapproved Eye Drugs

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FDA warns eight companies that they are illegally marketing unapproved ophthalmic drugs.

CDER Defends Pepaxto Withdrawal Proposal

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CDER says the legal standard for withdrawing Oncopeptides ABs Pepaxto has been met and the agency should withdraw the drug to prot...

2 FDA Recommendations in Patient Safety Report

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A Presidents Council of Advisors on Science and Technology report on patient safety includes two recommendations for FDA action.

White Paper on Preventing Drug Shortages

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A white paper by the Duke Margolis Center for Health Policy calls for a new government coordinating effort, the Prevent Drug Short...

Panel Votes Down OTC Cold Ingredient

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An FDA advisory committee votes 16 to 0 that current scientific data do not support the effectiveness of the over-the-counter phen...

Mallinckrodt Recalls One-Way Ventilator Valve

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Mallinckrodt recalls its One-Way Valve, 22F x 22M due to reports about the devices not opening properly, which prevents or reduces...

Jury Convicts 2 for Clinical Trial Fraud

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A Florida federal jury finds two defendants guilty of conspiring to falsify clinical trial data for profit.

OTC Drug User Fee Rates

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Federal Register notice: FDA announces the over-the-counter (OTC) monograph order request fee rates under the OTC monograph drug u...

FDA Permanently Debarring Tatsene

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Federal Register notice: FDA issues an order to permanently debar Mayya Tatsene from providing services in any capacity to a perso...