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FDA Clears Joimax Probes

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FDA posts a draft guidance document on Product Labeling for Certain Ultrasonic Surgical Aspirator Devices that provides labeling r...

Links to Disease Web Sites Cause Confusion: Study

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CDER researchers say that links to disease awareness Web sites from branded prescription drug sites may lead to confusion and misp...

Mylan Files BLA for Herceptin Biosimilar

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Mylan files a BLA for MYL-1401O, a proposed biosimilar copy of trastuzumab (Genentechs Herceptin), indicated to treat certain HER2...

NDA Accepted for Sickle Cell Treatment

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FDA accepts an Emmaus Life Sciences NDA for its orally administered pharmaceutical grade L-glutamine treatment for sickle cell dis...

Switch to Partial Approvals for Drugs: Commentators

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Two professors say FDA should use a partial-approval system for drugs rather than the currently all-or-nothing approach.