FDA Publishes 200+ CRLs For Increased Transparency

By Katie Anderson, Chief Editor, Pharmaceutical Online

On July, 2025, The U.S. Food and Drug Administration (FDA) published over 200 complete response letters (CRLs) to new drug applications and biologics license applications approved between 2020 and 2024. The letters were made available to increase transparency and help sponsors reduce similar mistakes in the future.

When the FDA cannot approve a drug application in its current state, it issues a CRL. These are most commonly for safety and efficacy concerns, manufacturing deficiencies and bioequivalence issues. These deficiencies are detailed in the letter and may also include recommendations for addressing them.

“For far too long, drug developers have been playing a guessing game when navigating the FDA,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Drug developers and capital markets alike want predictability. So today we’re one step closer to delivering it to them, with an ultimate goal of bringing cures and meaningful treatments to patients faster.”

The FDA is hoping that publishing the CRLs will shed light on common mistakes to help drugs get to market quicker. It is also hoping to encourage transparency with drug sponsors when communicating results with stakeholders and the public.

The CRLs published to the public at openFDA were redacted for trade secrets and confidential commercial information, as they have since been approved. There will be more CRLs published by the FDA in the near future.