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Botanical Drug Review MAPP Out

[ Price : $8.95]

CDER issues a MAPP on the review of INDs and NDAs for botanical drug products.

FDA Clears Syneron Medicals Profound Device

[ Price : $8.95]

FDA clears Syneron Medicals Profound microneedling device for improving cellulite appearance.

FDA Clears Joimax Probes

[ Price : $8.95]

FDA clears two Joimax electrosurgical probes.

Trump Expected to Bring Big Changes to FDA

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Notwithstanding president-elect Donald Trumps failure to publish a written policy platform, objective assessments of his public st...

Rule Discourages Petitions Seeking to Delay ANDAs

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Federal Register Final Rule. FDA amends certain regulations relating to citizen petitions to discourage their use to improperly de...

Guidance on Non-inferiority Trials

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Federal Register Notice: FDA makes available a guidance on Non- Inferiority Clinical Trials to Establish Effectiveness.

FDA Denies Petition on Probiotic Suppositories as Supplements

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FDA denies a ProbioTech petition filed in April that asked the agency to change the definition of a dietary supplement under the D...

FDA Draft Guide on Ultrasonic Surgical Aspirators

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FDA posts a draft guidance document on Product Labeling for Certain Ultrasonic Surgical Aspirator Devices that provides labeling r...

Industry Seeks More Off-label Use Dissemination Freedom

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Drug and device industries urge FDA to revise its off-label dissemination policies to allow needed dialogs with payers and the med...

QS Violations Found in Valeant Inspection

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FDAs New York District Office warns Valeant Pharmaceuticals about Quality System regulation problems in its development of specifi...