Capture

Reference Listed Drugs (RLD) Access Inquiries

Prospective generic applicants are unable to obtain samples of the reference listed drug (RLD) necessary to support their ANDA 

  • RLD sponsor imposed limitations on distributions
  • Subject to Risk Evaluation and Mitigation Strategies (REMS) impacting distribution

FDA providing transparency regarding these inquiries

  • Published a list of all drug products with FDA inquiries on RLD access
  • Details on RLD sponsor
  • Update this list on a semi-annual basis.

Part of Drug Competition Action Plan, to expand access to safe, high quality, effective generic medicines and lower drug cost

READ

RLD Website


 


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