FDA BRIEF: Week of December 19, 2016
Academic Medical Centers and FDA – Working Together for the Future
By: Robert M. Califf, M.D., Commissioner
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.
- 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
FDA-regulated products account for about 20 cents/dollar by U.S. consumers – have /need to report
- 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
- 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.
- FDA Consumer Complaint Coordinator
- FDA non-emergency reporting page
- local FDA Consumer Complaint Coordinator.