December 2016 – Drug and Device Digest

FDA News: Academic Medical Centers and FDA

FDA BRIEF: Week of December 19, 2016


Academic Medical Centers and FDA – Working Together for the Future

By: Robert M. Califf, M.D., Commissioner

Robert Califf 

FDA and academic medical centers (AMCs) have a history of working together

  • basic science of medicine
  • fundamental concepts for medical tools
  • regulatory science programs

Focus to better understand and advance AMC interactions

  • Shared commitment to ameliorating and curing disease, promoting public health
  • Spinning off biotech startups
  • Working directly with private corporations, state and federal partners, entrepreneurs
  • Harnessing unprecedented amount of data on human genome, human behavior, how much people earn and spend, the environmental conditions  etc.

FDA role

  • Helping to maintain and hold everyone to a high standard while driving innovation forward.
  • Continue to communicate and engage with each other, collaborate to advance shared missions


Reporting Product Problems and Complaints to the FDA

Image result for Business

FDA-regulated products account for about 20 cents/dollar by U.S. consumers – have /need to report

Which products: 

  • human prescription and over-the-counter (OTC) drugs
  • medical devices
  • foods, including dietary supplements, infant formulas, beverages, and ingredients added to foods
  • veterinary products, including foods and drugs for animals
  • electronic products that give off radiation
  • biologics, including vaccines, blood and blood components, and tissues for transplantation
  • cosmetics


  • FDA assesses information on problems or unexpected reactions/unknown risk
  • Can lead to labeling update, safety messages or removal of product from market


  • Unexpected side effects or adverse events
  • Product quality problems
  • Potentially preventable mistakes
  • Therapeutic failures

How:  Online, phone, mail.



Scroll to Top