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

FDA BRIEF: Week of May 8, 2017

Image result for scott gottlieb fda images

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

READ


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

READ

Scroll to Top