Category Archives: FDA

Implementing the Generic Drug User Fee Act: Struggles and Successes

Two years into the Generic Drug User Fee Act (GDUFA) program, enacted in July 2012, FDA officials are striving to meet goals and timelines for speeding new generic drugs to market. Agency reviewers have made some progress in eliminating the huge backlog in abbreviated new drug applications (ANDAs) pending in the Office of Generic Drugs […]
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FDA Announces Diagnostic Testing Measures

FDA has announced it is taking steps to ensure that certain diagnostic tests are accurate, consistent and reliable. The Agency is first issuing a final guidance on the development, review and approval or clearance of companion diagnostics, which are commonly used to detect certain types of gene-based cancers. Second, it will publish a risk-based oversight […]
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Catching Biopharmaceutical Sponsors by Surprise

The FDA has always been concerned about the safety of patients, and they strongly believe that clinical trials are not sufficient to capture all drug related adverse effects. During an update on The Future of FDA’s Drug Safety Program, Andrew C. von Eschenbach stated, “The full magnitude of some potential risks does not always emerge […]
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Sandoz Wins Biosimilar Filing Race

 After months of speculation about prospects for biosimilar development in the U.S., Novartis announced July 24 that FDA has accepted Sandoz’ biologics license application (BLA) for a similar version of Amgen’s Neupogen (filgrastim). Assuming FDA approval within a year, this action sets the stage for testing whether and how biosimilars will gain acceptance in the […]
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Compounding Pharmacy Issues Recall, But Challenges FDA Decision

FDA has posted on www.fda.gov a July 19, 2014 press statement from Unique Pharmaceuticals, which reports a voluntary nationwide recall of all sterile drug preparations compounded by the outsourcing facility that have not reached the expiration date listed on the products.
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