FDA Announces Draft Guidance for Industry Regarding Accelerated Approval for Drugs and Biologics

On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA. Judge Jordan’s decision vacates and sets aside the Food & Drug Administration’s (FDA) final rule, Medical Devices; Laboratory Developed Tests (the LDT Rule).¹ The LDT Rule would have required laboratories offering LDTs to meet medical device requirements. The preamble to the LDT Rule provided a multi-stage phase out of FDA’s enforcement discretion policy, under which the first set of regulatory requirements would have been actively enforced beginning May 6. While many labs are breathing a sigh of relief after the publication of this order, questions remain as to how the agency will proceed and the broader implications for regulation of lab tests and in vitro diagnostics generally.

In the past week, the U.S. Food and Drug Administration (FDA), in collaboration with the Department of Health and Human Services (HHS) announced three new initiatives related to food safety and food supply chain transparency. Outlined below, these new initiatives align with HHS Secretary Robert F. Kennedy Jr.’s recent announcements to focus on bolstering food safety, including the recent directive to the FDA to explore the revision of the longstanding Generally Recognized as Safe (GRAS) rule.

The Food and Drug Administration (FDA) has updated its website to provide new information on data integrity concerns relating to medical devices.

United States Department of Health and Human Services (HHS) Secretary Kennedy recently directed the U.S. Food and Drug Administration (FDA) to consider rulemaking to revise its longstanding regulations and guidance governing the oversight of food ingredients to eliminate the ability of individuals and companies to self-affirm that their ingredients are Generally Recognized as Safe (GRAS). This would mark a massive shift in how new food ingredients are introduced to the market.

In the final stretch of the Biden administration, the Food and Drug Administration (FDA) laid the groundwork for continued engagement with the public on two challenging areas of product development, each of which is of high interest to patients, clinical communities, industry stakeholders and policy-makers in Congress.

On January 6, 2025, the FDA released final guidance for industry entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers.” The guidance outlines FDA’s enforcement policy concerning certain firm-initiated communications of scientific information on unapproved uses (SIUU) of the firm’s approved or cleared medical products to health care providers involved in prescribing or administering those products to individual patients. It finalizes the October 2023 draft guidance, which itself revised draft guidance from 2014 and 2009. The latest guidance is not for current implementation and is pending the Office of Management and Budget’s (OMB) approval of the guidance’s information collection provisions.

On January 15, 2025, FDA announced an order revoking the listings providing for the use of the color additive FD&C Red No. 3 in both foods (including dietary supplements) and ingested drugs. The order is in response to a 2022 petition filed by the Center for Science in the Public Interest, among other food safety and health advocates, which asserted that the additive induces cancer in male rats and urged the agency to revoke authorization. 

On January 7, the FDA made available draft guidance on the development of drugs and biological products for weight reduction within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance of body weight in patients with obesity or who are overweight. Notably, this draft guidance includes recommendations with respect to the clinical assessment of weight reduction drugs in both adults and pediatric patients, revising and replacing the draft guidance for industry “Developing Products for Weight Management” issued in February 2007.