Anna Abram at Akin Gump Strauss Hauer & Feld LLP

FDA Dives Deeper into the Use of Digital Health Technologies in Drug Development with New RFI

On March 31, 2026, the Food and Drug Administration (FDA) published a notice in the Federal Register requesting information and public comment (RFI) on the use of digital health technologies (DHTs) in clinical investigations...more

4/9/2026 / Biotechnology , Center for Biologics Evaluation and Research (CBER) , Center for Drug Evaluation and Research (CDER) , Clinical Trials , Comment Period , Digital Health , Federal Register , Food and Drug Administration (FDA) , Prescription Drugs , Request For Information

FDA Presses Forward on Incorporating Patient Preferences in Device Decision Making, Releases Updated Final Guidance

On March 30, 2026, the Food and Drug Administration (FDA) published a final guidance entitled “Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle.” The guidance provides updated...more

4/2/2026 / 21st Century Cures Act , Final Guidance , Food and Drug Administration (FDA) , Medical Devices , Patients , Regulatory Requirements

FDA Announces Public Hearing and Opportunity to Comment on National Priority Voucher Pilot Program

On March 20, 2026, the Food and Drug Administration (FDA) announced the agency will hold a public hearing on the Commissioner’s National Priority Voucher (CNPV) Pilot Program, with a Federal Register notice soliciting public...more

3/25/2026 / Biologics , Center for Biologics Evaluation and Research (CBER) , Center for Drug Evaluation and Research (CDER) , Drug Approvals , Food and Drug Administration (FDA) , Pilot Programs , Prescription Drugs , Priority Review Vouchers , Public Comment , Public Health

FDA and NIH Take Actions to Reduce Reliance on Animal Testing with New Draft Guidance and Funding Announcement

On March 18, 2026, the Food and Drug Administration (FDA) issued draft guidance entitled “General Considerations for the Use of New Approach Methodologies in Drug Development.” The guidance is meant to provide drug developers...more

3/23/2026 / Animal Testing , Biotechnology , Draft Guidance , Federal Funding , Food and Drug Administration (FDA) , Life Sciences , National Institute of Health (NIH) , Pharmaceutical Industry , Regulatory Oversight , Research and Development

Q&A: FDA Seeks to Clarify '3-Year Exclusivity' with New Guidance

In March 2026, the Food and Drug Administration (FDA) issued draft guidance for the industry, New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers, providing additional clarity...more

3/17/2026 / Abbreviated New Drug Application (ANDA) , Clinical Trials , Comment Period , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Hatch-Waxman , New Guidance , Pharmaceutical Industry , Regulatory Oversight , Regulatory Requirements

HHS Kicks Off Rare Disease Week with FDA Release of Draft Guidance on Plausible Mechanism Framework for Individualized Therapies

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

2/24/2026 / Biotechnology , Clinical Trials , Department of Health and Human Services (HHS) , Draft Guidance , Food and Drug Administration (FDA) , Medical Research , Public Health , Regulatory Oversight , Regulatory Requirements

Congress Rallies to Extend Rare Pediatric Disease Priority Review Voucher Program

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

2/17/2026 / Consolidated Appropriations Act (CAA) , Food and Drug Administration (FDA) , New Legislation , Pharmaceutical Industry , Prescription Drugs , Priority Review Vouchers , Public Health , Regulatory Authority , Reporting Requirements

PBM Reform Picks Up Pace with Enactment of Consolidated Appropriations Act, PBM Fee Disclosure Proposed Rule

Pharmacy benefit manager (PBM) reform has been an active and evolving area for policymakers in Washington, D.C. for many years but reform efforts have noticeably picked up pace in 2026. Recent actions by Congress and the...more

2/4/2026 / Consolidated Appropriations Act (CAA) , Department of Labor (DOL) , Disclosure Requirements , Drug Pricing , Employee Retirement Income Security Act (ERISA) , Executive Orders , Medicare Part D , Pharmacy Benefit Manager (PBM) , Proposed Rules , Reporting Requirements

CMS Launches Five New Models at the End of 2025: Looks to Advance ACCESS, BALANCE, MAHA ELEVATE, GLOBE and GUARD in 2026

The Centers for Medicare & Medicaid Services (CMS) Center for Medicare and Medicaid Innovation (CMMI) (Innovation Center) has unveiled a series of new models related to the administration’s focus on improving the health of...more

1/9/2026 / Alternative Payment Models (APM) , Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Medicaid , Medicare , Pharmaceutical Industry , Prescription Drugs , Proposed Rules , Value-Based Care

FDA Issues Key Guidance Updates for Digital Health and Wellness

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

1/7/2026 / 21st Century Cures Act , Digital Health , Food and Drug Administration (FDA) , General Wellness Devices , Guidance Documents , Medical Devices , New Guidance , Regulatory Oversight , Regulatory Reform , Software

FDA’s TEMPO Pilot Seeks to Expand Access to Chronic Disease Technologies in CMS Collaboration

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

12/16/2025 / Centers for Medicare & Medicaid Services (CMS) , Digital Health , Food and Drug Administration (FDA) , Healthcare , Innovation , Medical Devices , Public Health , Regulatory Oversight , Regulatory Requirements , Risk Management

An Overview of the Over-the-Counter Monograph Drug User Fee Amendments (OMUFA): Policy Areas to Watch

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

11/18/2025 / Animal Testing , Fees , Food and Drug Administration (FDA) , GAO , New Legislation , Over The Counter Drugs (OTC) , Prescription Drugs , Real World Evidence , Supply Chain

FDA Issues Draft Guidance with Updated Recommendations for Assessing the Need for Comparative Efficacy Studies in Biosimilar...

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

11/6/2025 / Biosimilars , Biotechnology , Clinical Trials , Draft Guidance , Life Sciences , New Guidance , Pharmaceutical Industry , Regulatory Oversight , Regulatory Requirements

FDA Presses Forward on Patient-Focused Drug Development, Releases Final Guidance Focused on Fit-For-Purpose Clinical Outcome...

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

10/28/2025 / 21st Century Cures Act , Clinical Trials , Final Guidance , Food and Drug Administration (FDA) , Patients , PDUFA , Pharmaceutical Industry , Regulatory Oversight , Regulatory Requirements , Research and Development

FDA Names the First Nine National Priority Voucher Recipients

On October 16, 2025, the Food and Drug Administration (FDA) unveiled the first group of nine voucher recipients under the Commissioner’s National Priority Voucher (CNPV) pilot program, a program announced by the agency...more

10/24/2025 / Biologics , Drug Pricing , Expedited FDA Approval , Food and Drug Administration (FDA) , Manufacturers , Pharmaceutical Industry , Pilot Programs , Public Health , Regulatory Agencies , Regulatory Reform

FDA Continues Focus on AI Fronts, Seeks Public Comment on Measuring and Evaluating AI-enabled Medical Device Performance in the...

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

10/10/2025 / Artificial Intelligence , Best Practices , Digital Health , Food and Drug Administration (FDA) , Machine Learning , Medical Devices , Public Comment , Real World Evidence , Regulatory Oversight , Risk Management

The Trump Administration Continues to Make Drug Pricing Moves, Announces First MFN Agreement

Lowering drug prices for American patients continues to be a key area of focus and activity for the Trump administration. In May, the President issued the “Delivering Most-Favored-Nation Prescription Drug Pricing to American...more

10/2/2025 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Executive Orders , Food and Drug Administration (FDA) , Medicaid , Pharmaceutical Industry , Prescription Drugs , Tariffs , Trump Administration

FDA Presses Forward on PDUFA VII CGT Commitments with Release of Draft Guidance on Clinical Trial Design, Methods for Capturing...

FDA recently released two draft guidance documents for industry related to cell and gene therapy (CGT) products as the agency seeks to advance the efficient development and review of safe and effective CGT products and...more

9/30/2025 / Biotechnology , Clinical Trials , Data Collection , Data Management , Data Privacy , Draft Guidance , Food and Drug Administration (FDA) , PDUFA , Pharmaceutical Industry , Regulatory Requirements

FDA’s Latest on Emergency Diagnostics and a No-Frills Rescission of the LDT Rule

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

9/25/2025 / Diagnostic Tests , Emergency Use Authorization (EUA) , Final Rules , Food and Drug Administration (FDA) , Laboratory Developed Tests , Medical Devices , New Guidance , Public Health , Rescission

FDA Puts Orange B on the Chopping Block

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

9/24/2025 / Chemicals , Comment Period , Federal Food Drug and Cosmetic Act (FFDCA) , Food & Drug Regulations , NPRM , Proposed Rules , Public Health , Regulatory Reform , Rulemaking Process

From Foods to Pharmaceuticals, MAHA Strategy Offers Broad Menu of FDA Actions

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

9/16/2025 / Clinical Trials , Department of Health and Human Services (HHS) , Digital Health , Food and Drug Administration (FDA) , Food Labeling , Food Safety , Government Agencies , Pharmaceutical Industry , Public Health , USDA

FDA Continues Focus on Rare Disease Drug Development, Announces Evidence Principles

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

9/8/2025 / Center for Biologics Evaluation and Research (CBER) , Center for Drug Evaluation and Research (CDER) , Clinical Trials , Food and Drug Administration (FDA) , New Guidance , Orphan Drugs , PDUFA , Pharmaceutical Industry , Prescription Drugs , Regulatory Requirements

Five Health Care Issues to Watch as Congress Returns from August Recess

Health care is a consistently active area for policymakers on Capitol Hill. This alert highlights five health policy issues to watch as Congress returns from August recess. While the fiscal year 2026 (FY26) appropriations...more

9/3/2025 / Affordable Care Act , Congressional Committees , Continuing Resolution , Drug Pricing , Federal Budget , Food and Drug Administration (FDA) , Medicaid , Medicare , Over The Counter Drugs (OTC) , Pharmacy Benefit Manager (PBM)

Congress Joins FDA in Focusing on Food Dye Limitations

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

8/28/2025 / Executive Orders , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Food Safety , New Legislation , Proposed Legislation , Regulatory Oversight , Regulatory Reform , State and Local Government , Trump Administration

OMUFA Reauthorization On Deck as Congress Returns from Recess

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

8/27/2025 / Department of Health and Human Services (HHS) , Executive Orders , Fees , Food and Drug Administration (FDA) , New Legislation , Over The Counter Drugs (OTC) , Prescription Drugs , Regulatory Reform , Senate Committees , Trump Administration

Anna Abram

Akin Gump Strauss Hauer & Feld LLP

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