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FDA posts a draft guidance document on Product Labeling for Certain Ultrasonic Surgical Aspirator Devices that provides labeling r...

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...

Late Petitions Cant Delay ANDA Approval

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FDA says a final rule taking effect 1/9/17 aims to prevent late citizen petitions or petitions for a stay of action from delaying ...

Firm Compounding Unapproved Domperidone Product: FDA

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FDAs San Francisco District Office warns Innovative Compounding Pharmacy about CGMP violations in its compounding of unapproved do...

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...