dispute_header

WHAT: Formal Review of scientific and/or medical disputes. Related to applications for user fee products.  To quickly and impartially investigate complaints and resolve disputes between CDER and CDER-regulated industry, health care practitioners, and consumers by offering an informal, confidential, and neutral environment

HOW: Process codified in Code of Federal Regulations (CFR) and  CDER/CBER Guidance for Industry

WHO:  FDA contacts:

  • CDER Formal Dispute Resolution Project Manager
  • Ombudsman

Dispute

LINK1

LINK2


 

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