FDA News: Payer Communication Task Force, Clinical InvestigatorTraining, BEST, Symbols in Labeling
FDA BRIEF: Week of September 26,2016
Payer Communication Task Force (PCTF)
CDRH initiative to shorten the time between FDA approval or clearance and device coverage
- PCTF for public/private payer organizations to provide input on clinical evidence to support coverage decisions.
- Centers for Medicare and Medicaid Services (CMS) : Parallel Review Pilot Program initiated
- Private payers (Tabulated below): Expressed interest in attending Pre-Submission meetings to provide clinical evidence input
FDA’s Clinical Investigator Training Helps Support the Drug Development Process
By:
Leonard Sacks, M.D., Associate Director for Clinical Methodologies, Office of Medical Policy, CDER
Mili Duggal, Ph.D., M.P.H., ORISE Fellow, Office of Medical Policy, CDER
7th Annual Clinical Investigator Training Course
- For physicians, nurses, pharmacists, and other healthcare professionals
- Design, conduct, and evaluation of clinical trials
- Training by senior FDA experts and guest speakers
- Investigators could learn directly from FDA staff and interact with them
Biomarkers, EndpointS, and other Tools (BEST) Resource
- FDA-NIH Joint Leadership Council harmonized of terms used in translational science and medical product development
- BEST developed to promote consistent use of biomarker terms and concepts
- Clarifies terminology and uses of biomarkers and endpoints as they pertain to the progression from basic biomedical research to medical product development to clinical care
Using Symbols to Convey Information in Medical Device Labeling
By:
Antoinette (Tosia) Hazlett, MSN, RN, Senior Policy Analyst, CDRH
Scott Colburn CAPT, USPHS, Director, CDRH Health Standards Program
Symbols on medical devices need to be understood by users
Use of Symbols in Labeling final rule in 06/2016
- not to use symbols
- use symbols with adjacent explanatory text
- use stand-alone symbols that have been established
Stand-alone symbols
- reduce design costs
- consistent with EU and other foreign market labeling
- replace small and difficult-to-read text
- more user-friendly and understandable
Symbols Glossary : help user familiarity
Symbol Statement “Rx Only” or “℞ only” : For prescription devices