FDA Authorizes Marketing for First Combination Flu and COVID-19 At-Home Test Outside of Emergency Use

The Food and Drug Administration (FDA) continued its efforts to modernize drug development and regulation with the recent publication of a notice in the Federal Register from the Center for Drug Evaluation and Research’s (CDER) Quantitative Medicine Center of Excellence announcing a request for information (RFI) to inform the development of the Quantitative Medicine Innovation Network (QMIN). The agency is seeking to better understand current quantitative medicine capabilities, challenges, and opportunities and specific feedback on how it might shape the structure, priorities and activities of this proposed collaborative ecosystem to advance the science and application of quantitative medicine in furtherance of public health.

On July 22, 2026, the Food and Drug Administration (FDA) announced two additional steps in its ongoing effort to phase out petroleum-based color additives from the U.S. food supply. Specifically, the agency issued a final order revoking the authorization for Orange B and proposed revoking the authorization for Citrus Red No. 2, both on the basis that their approved uses have been abandoned by industry. As discussed in our prior posts, FDA announced last year that it would work with industry to eliminate petroleum-based synthetic dyes by the end of 2026, and Congress has since joined the conversation with legislation targeting several commonly used food dyes.

On June 24, 2026, the Food and Drug Administration (FDA) published a notice of availability in the Federal Register requesting information and public comment on an Expedited Investigational New Drug (IND) pilot program. The proposed pilot program is part of the Trump administration’s focus on taking steps to strengthen America’s leadership in clinical research, accelerate the development of lifesaving treatments and ensure that patients have access to the most innovative therapies in the world.

On June 2, 2026, the U.S. Food and Drug Administration (FDA) issued draft guidance on how drug and device companies may communicate health care economic information (HCEI) with payors (e.g., health insurance companies), formulary committees (e.g., pharmacy and therapeutics committees) and similar entities. The guidance, Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers, is now open for comment.