FDA BRIEF: Week of April 25 2016


MDUFA

 

STAKEHOLDERS : Duke University, National Center for Health Research, Alliance for Aging Research, Epilepsy Foundation, National Coalition for Cancer Survivorship, National Health Council, American College of Cardiology, American Academy of Neurosurgery,  FasterCures, Society for Women’s Health Research, Pew Charitable Trusts, National Organization for Rare Disorders, Research!America, Avalere Health

  • FDA discussed the current status of proposals

-Cost of additional enhancements to program as identified by Industry

-Industry vs FDA areas of interest and priority

-Additional discussions needed to close gap in priority assessments

  • FDA presentation: Inter-center consultation review process for combination products

-History and Challenges

-Recommendations: Increased collaboration, review consistency, improved IT access, expedited data access, standardized processes and guidances

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