JD Supra

FDA Publishes Complete Response Letters for Unapproved Drug Applications

On September 4, 2025, the US Food and Drug Administration (FDA or the Agency) announced that it released a second batch of complete response letters (CRLs) — which explain the Agency’s determination ...
Monthly Prescribing Reference

FDA Publishes Full Texts of Response Letters to Drug Applications

The issues addressed in these letters are usually related to "safety and efficacy concerns, manufacturing deficiencies, and bioequivalence issues." HealthDay News — The US Food and Drug Administration ...
The American Journal of Managed Care

MDMA-Assisted Therapy Receives a Complete Response Letter From the FDA

Today, the FDA issued a complete response letter (CRL) for midomafetamine capsules (MDMA) in combination with assisted therapy (MDMA-AT) for adults living with posttraumatic stress disorder (PTSD).
Morningstar

FDA Plans Real-Time Release of Complete Response Letters

The U.S. Food and Drug Administration said it will begin publishing rejection letters sent to drugmakers in real time as part of the agency's push for increased transparency. The FDA on Thursday said ...