FDA BRIEF: Week of May 2, 2016

 

PFDD_Parkinson

  • Part of FDA’s Patient-Focused Drug Development initiative
  • Obtain input from patients, caretakers,patient representatives on : (1) Effects of Parkinson’s disease that matter most to patients and (2) Patients’ perspectives on treatments for Parkinson’s disease.

Key Themes

  • Progressive, devastating disease: Difficulty of living with the unexpected onset and progression of symptoms – bradykinesia, dyskinesia, tremor, dystonia, sleep disturbances, cognitive impairment, fatigue, and constipation.
  • Impacts all aspects of patients’ lives: Severe limitations in performing at work, caring for self and family, and maintaining relationships and emotional toll
  • Complexity of disease management: Selection of options, timing, pill burden, adjustments to daily changes in symptoms
  • Using combination of drug and non-drug treatments. For optimal symptom management
  • Need for medications for delaying symptom onset or slowing symptom progression 

READ


 

FDA Voice

 

EvGen Part II:

Building Out a National System for Evidence Generation

shermancaliff

Rachel E. Sherman, M.D., M.P.H., Associate Deputy Commissioner

Robert M. Califf, M.D., Commissioner 

 

EvGen Part I posted previously in this  blog

Need to remove barriers to data sharing

  • Common approach for data presentation, reporting and analysis
  • Transparent rules of engagement across all stakeholders
  • Output public good and readily accessible to all stakeholders.

Vision for EvGen

  • Common attributes for drug/biologic/device reviews: Characterization of individuals and populations and associated clinical outcomes
  • Secondary use(s) of data in related fileds

Examples of Related Initiatives

  • Sentinel Initiative
  • National Patient-Centered Clinical Research Network (PCORnet)
  • NIH Health Care Systems Research Collaboratory
  • Reagan-Udall Foundation Innovation in Medical Evidence Development and Surveillance (IMEDS) Evaluation Program
  • National Device Evaluation System (NDES)

More in future postings

READ

 

 

 

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