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

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RLD Website