On February 23, 2026, the Food and Drug Administration (FDA) released a draft guidance entitled “Considerations for the Use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic...more
On February 3, 2026, the Consolidated Appropriations Act, 2026 (P.L. 119-75) became law and marked an important milestone in the bipartisan congressional effort to reauthorize the rare pediatric disease priority review...more
In case you missed it, Department of Health and Human Services Secretary Robert F. Kennedy Jr. and former Food and Drug Administration (FDA) Commissioner David Kessler appeared on 60 Minutes this past Saturday, February 15,...more
It is no exaggeration to say that the past year has seen the most significant push to reform the U.S. Food and Drug Administration’s (FDA) generally recognized as safe (GRAS) process in more than two decades (see our prior...more
On February 1, 2026, the Food and Drug Administration (FDA) officially started accepting requests to participate in the FDA PreCheck pilot program. The goal of the program is to strengthen the domestic pharmaceutical supply...more
The Food and Drug Administration (FDA) has begun 2026 with a clear signal to the direct‑to‑consumer testing industry: self‑collection devices remain firmly within the agency’s regulatory reach, notwithstanding the 2025 court...more
On January 7, 2026, the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA) released the highly anticipated 2025-2030 Dietary Guidelines for Americans (DGA). At roughly 10 pages,...more
On January 6, the Food and Drug Administration (FDA) updated its guidance documents on Clinical Decision Support (CDS) software and general wellness products, and withdrew its guidance on the adoption of international...more
On December 18, 2025, the Food and Drug Administration (FDA) released a final guidance entitled “Processes and Practices Applicable to Bioresearch Monitoring Inspections.” The guidance was issued to comply with the Food and...more
On December 18, the BIOSECURE Act became law as Sec. 851 of the National Defense Authorization Act (NDAA) for Fiscal Year 2026. The BIOSECURE Act will prohibit the U.S. government from contracting with any company that uses...more
12/22/2025
/ BIOSECURE Act ,
Biotechnology ,
China ,
Department of Defense (DOD) ,
Federal Acquisition Regulations (FAR) ,
Federal Contractors ,
Life Sciences ,
Medicare ,
New Legislation ,
Pharmaceutical Industry ,
Supply Chain
On December 5, 2025, FDA announced its Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, a new voluntary pilot that seeks to accelerate innovation and expand access to digital health...more
Artificial intelligence is rapidly transforming clinical medicine, with AI-powered tools increasingly being used for diagnostic imaging interpretation, clinical decision support, predictive analytics and treatment planning....more
12/11/2025
/ Algorithms ,
Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Digital Health ,
Food and Drug Administration (FDA) ,
Healthcare ,
Machine Learning ,
Medical Devices ,
Popular ,
Regulatory Oversight ,
Regulatory Requirements
On November 12, 2025, President Trump signed H.R. 5371, the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026, into law (P.L. 119-37). In addition...more
Last week, FDA released draft guidance titled “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies.” This draft...more
On October 21, 2025, the Commerce Department’s International Trade Administration (ITA) announced the launch of the American AI Exports Program following President Trump’s July 23 executive order (EO) on Promoting the Export...more
On October 23, 2025, FDA released its final guidance regarding Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments. The guidance is the third guidance in a...more
On September 30, 2025, the Food and Drug Administration (FDA) published a Request for Public Comment to obtain feedback from interested parties on current approaches to measuring and evaluating the performance of AI-enabled...more
On Tuesday, September 23, 2025, FDA published guidance titled “Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency.” The guidance, a draft of which was published on May...more
Last week, the U.S. Food and Drug Administration (FDA) issued a proposed rule to revoke the color additive listing for Orange B, a synthetic dye historically used on the casings and surfaces of frankfurters and sausages. This...more
The White House’s Make America Healthy Again (MAHA) Commission, led by the Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., released its highly anticipated strategy outlining a multi-agency...more
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...more
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...more
In March 2020, Congress enacted the first Over-the-Counter (OTC) Monograph Drug User Fee program (OMUFA) as part of the CARES Act (P.L. 116 – 136) to modernize the Food and Drug Administration’s regulation of OTC monograph...more
White House Releases America’s AI Action Plan On July 23, 2025, the White House released America’s AI Action Plan. The plan, initiated by President Donald J. Trump's Executive Order 14179, "Removing Barriers to American...more
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...more