FDA News: Payer Communication Task Force, Clinical InvestigatorTraining, BEST, Symbols in Labeling – Drug and Device Digest

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

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FDA’s Clinical Investigator Training Helps Support the Drug Development Process


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 


Leonard Sacks

Mili Duggal

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 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


Antoinette (Tosia) Hazlett, MSN, RN, Senior Policy Analyst, CDRH

Scott Colburn CAPT, USPHS, Director, CDRH Health Standards Program

Tosia Hazlett

Scott Colburn

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



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