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FDA takes steps to clarify significant human tissue questions

USA - November 4 2015 On October 30, 2015, the Food and Drug Administration (FDA) issued a draft guidance document, Homologous Use of Human Cells, Tissues, and Cellular…

Arthur E. Kim, Mike Druckman, Randy Prebula

Current trends in FDA’s pharmaceutical good manufacturing practice (GMP) warning letters

USA - April 22 2009 In the past twelve months, the U.S. Food and Drug Administration (FDA) has issued more than 25 Warning Letters to manufacturers of finished pharmaceuticals and active pharmaceutical ingredients (APIs) for violations of the current good manufacturing practice (GMP) regulations.

Stephen C. Mahoney

NIH's Clinical Trial Initiatives

USA - November 15 2016 Over the past few months, the National Institutes of Health (NIH) has unveiled several policies that add to the long list of regulatory obligations…

William F. Ferreira, Heidi Gertner

There'll Be Some Changes Made: President Signs Prescription Drug and Biologic User Fee Reauthorization Act

USA - August 21 2017 On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support…

George A. O'Brien, James S. Allred, Mike Druckman, Heidi Gertner, David Horowitz, Komal A. Karnik, Bert Lao, Katelyn (Katie) Ruiz Medwid, Gary Veron

United States v. Palazzo: FDA and DOJ turn up the heat on clinical trial enforcement

USA - March 24 2009 On February 6, 2009, the U.S. Court of Appeals for the Fifth Circuit ruled in United States v. Palazzo that a clinical investigator can be held criminally liable for failing to comply with regulations of the U.S. Food and Drug Administration (FDA) that impose record-keeping and reporting requirements for clinical studies.