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USA - November 4 2015 On October 30, 2015, the Food and Drug Administration (FDA) issued a draft guidance document, Homologous Use of Human Cells, Tissues, and Cellular…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