FDA Opens the Vault on Decision Letters—Releases Wave of Drug and Biologic CRLs

On September 3, 2025, the Food and Drug Administration (FDA) announced Rare Disease Evidence Principles (RDEP) with processes aimed at providing greater predictability and facilitating the development and review of drugs intended to treat rare diseases with very small patient populations and significant unmet medical needs driven by a known genetic defect. In conjunction with the agency’s announcement of the new processes jointly proposed by the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), the agency also unveiled additional information regarding eligibility and the potential for post-marketing requirements for those sponsors who participate in it.

Food dye reform has been an area of focus for the Trump administration as part of its Make America Healthy Again (MAHA) initiative, giving momentum to an effort the Food and Drug Administration (FDA) had already started by banning Red No. 3 for use in food and ingested drugs. FDA has continued to prioritize this work by taking actions to phase out the use of synthetic dyes and move to natural dyes since calling for these changes earlier this year, as discussed in our previous blog on the related announcement by the administration.

Last week, former Food and Drug Administration (FDA) Commissioner David Kessler submitted a citizen petition urging FDA to revoke the generally recognized as safe (GRAS) status of refined carbohydrates used in industrial food processing. The petition follows FDA’s and the United States Department of Agriculture’s (USDA) joint request for information (RFI) to establish a formal definition for ultra-processed foods (UPFs) and offers FDA a legal pathway to change the regulatory status of these ingredients.

On August 6, 2025, the U.S. Food and Drug Administration (FDA) became the latest governmental agency to confirm that fluoropolymers are both safe and necessary. After an independent safety review of fluoropolymers in medical devices showed no conclusive evidence of health issues, FDA concluded that fluoropolymers are “very unlikely to cause toxicity” because of molecular size and further that they are essential for medical devices to function. As a result, “FDA’s evaluation is that currently there is no reason to restrict their continued use in devices.” This announcement will be a source of relief to the device and diagnostics industries.

On July 25, the U.S. Food and Drug Administration (FDA), in collaboration with the U.S. Department of Health and Human Services (HHS) and U.S. Department of Agriculture (USDA), unveiled the highly anticipated joint request for information on ultra-processed foods (UPFs). Specifically, the administration is seeking information and data to help develop a uniform definition for UPFs in the U.S. food supply.

Dr. George Tidmarsh has been selected to replace Dr. Jacqueline Corrigan-Curay as the director of the Center for Drug Evaluation and Research (CDER) at FDA as she prepares to retire from the agency. Dr. Tidmarsh is an adjunct professor of pediatrics and neonatology at Stanford University and is credited as having been involved in the development of several approved drugs. Until late May of this year, Dr. Tidmarsh was a member of the board of directors of Revelation Biosciences, a company engaged in developing an anti-inflammatory IV therapy. Among other roles and experiences he has had, he was a founding Co-Director of Stanford’s Master of Science in Translational Research and Applied Medicine (M-TRAM) program, and founded Horizon Pharma in 2005.

Recently, it was reported that the U.S. Food and Drug Administration (FDA) is launching two cross-agency artificial intelligence (AI) councils. One AI council will be tasked with addressing how the agency uses AI internally and the other will focus on policy governing AI’s use in FDA-regulated products (reportedly pre-existing AI councils in various FDA divisions will continue to operate) (Politico Pro).

This week, the U.S. Food and Drug Administration (FDA) granted another color additive petition, approving the use of Gardenia (Genipin) in various food and beverage products. This marks the fourth naturally-derived color additive authorized for use in foods since FDA’s April announcement to phase out all petroleum-based synthetic dyes in food and transition to natural alternatives (read more here). Gardenia blue, derived from the fruit of the gardenia, a flowering evergreen, is now approved for use in sport drinks, flavored or enhanced non-carbonated water, fruit drinks and ades, ready-to-drink teas, hard candy and soft candy.