JD Supra

FDA’s Release of Complete Response Letters Raises Questions Related to Intellectual Property

In an unprecedented move, starting in July 2025, the U.S. Food and Drug Administration (FDA) released communications that have previously remained unpublished and confidential to the public.
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 ...
JD Supra

FDA’s Evolving Complete Response Letter Disclosure Practices: Impacts and Considerations

With the recent publication of numerous, previously unpublished complete response letters, coupled with its plans to increase these disclosures going forward, FDA has taken a significant step forward ...
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 ...
Renal & Urology News

FDA Publishes Full Texts of Response Letters to Drug Applications

The goal is to improve public understanding of the FDA decision-making process. (HealthDay News) — The U.S. Food and Drug Administration has published more than 200 complete response letters, or ...