FDA BRIEF: Week of September 26,2016

Voice


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

Displaying image.png

READ


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 

 

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

READ


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

READ


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

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

READ


 

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s