FDA News: 23rd Commissioner, Clinical Trial Protocol Template, Depression Treatments, Continuous Manufacturing – Drug and Device Digest

FDA BRIEF: Week of May 8, 2017

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Meet Scott Gottlieb, M.D., Commissioner of Food and Drugs

Dr. Scott Gottlieb was sworn in as the 23rd FDA Commissioner on May 11

  • Physician, medical policy expert, public health advocate
  • Previously served at FDA and CMS
  • Senate appointment to serve on Federal Health Information Technology Policy Committee


FDA and NIH Release Final Template for Clinical Trial Protocols

NIH-FDA Joint Leadership Council issued protocol template for drugs and medical devices:
  • Describing trial objectives, trial design, methodology, statistical considerations, and trial organization
  • Standard protocol format to facilitate review by regulators and others (e.g., institutional review boards)
  • Following ICH E6 Good Clinical Practice guidelines
  • Contributing to important time and money-saving efficiencies


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