FDA Reforms

Extracted Attributes

• Lead Official

  Marty Makary (FDA Commissioner)

• Nutrition Focus

  Shifting focus from fats to refined carbohydrates as a driver of obesity

• Primary Objective

  Accelerating drug approval and enhancing U.S. biotech competitiveness

• Research Priorities

  Microbiome-autism link, Type 1 Diabetes cure, and cell/gene therapy

• Clinical Trial Reform

  Reducing pivotal trials from two to one; implementing continuous trials

• Drug Pricing Strategy

  Most Favored Nation Status, biosimilar acceleration, and OTC expansion

• Governing Administration

  Donald Trump Administration

• Technological Integration

  AI for post-market surveillance, Bayesian statistics, and organ-on-a-chip technology

Timeline

• FDA publishes the Roadmap to Reducing Animal Testing in Preclinical Safety Studies. (Source: Food and Drug Administration: What to Watch in 2026 and Beyond)

  2025-04-01

• FDA issues announcements regarding baby food recalls and potential fast-tracking for drugs that equalize U.S. and international pricing. (Source: Recent FDA Actions Pose Big Changes and Questions for Health ...)

  2025-07-01

• Appropriations bill signed into law reauthorizing the Over-the-Counter Monograph Drug User Fee Program (OMUFA) through 2030. (Source: Food and Drug Administration: What to Watch in 2026 and Beyond)

  2025-11-12

• FDA updates its list of Recognized Consensus Standards, adding over 100 new and revised standards. (Source: FDA Reforms and Initiatives in 2026: Key Developments - LinkedIn)

  2025-12-22

• Commissioner Marty Makary details reform agenda during the JP Morgan Healthcare Conference in San Francisco. (Source: Supercharging A New FDA: Marty Makary on Science, Power & Patients)

  2026-01-15

• Scheduled expiration of various User Fee Agreements (UFAs) for prescription drugs, biologics, and medical devices. (Source: Food and Drug Administration: What to Watch in 2026 and Beyond)

  2027-09-30

History of the Food and Drug Administration

The Food and Drug Administration is a federal agency of the United States, formed in 1930.

Web Search Results

• FDA Reforms and Initiatives in 2026: Key Developments - LinkedIn

  # FDA Reforms and Initiatives in 2026: Key Developments This title was summarized by AI from the post below. Luke Oh Report this post These FDA reforms and initiatives seem to continue and evolve throughout 2026. Initiated National Priority Vouchers Accelerating Biosimilars Boosting Domestic Manufacturing: Modernizing Infant Formula Removing Artificial Food Dyes Unleashing Gene Therapies Fighting Concentrated 7-OH Rewriting Dietary Guidelines Reducing Animal Testing Fixing Opioid Labels Cracking Down on Pharma Ads AI-Assisted Reviews Made Decision Letters Public Prioritizing Rare Diseases Lowering Drug Prices 892,517 followers In 2025, the FDA implemented an agenda of bold reforms. We made a lot of progress — and we're just getting started. ### 2025 FDA Achievements #### 2 [...] To view or add a comment, sign in Reinhard Koehler + Report this post On December 22, the U.S. FDA updated its list of Recognized Consensus Standards, adding more than 100 new and revised standards. Link: 15 Like Comment To view or add a comment, sign in EMMA International 12,238 followers + Report this post [...] 12,238 followers + Report this post CDER increased its warning letters by 50% in FY 2025 — a clear signal that enforcement priorities are shifting. From GMP violations to misleading telehealth promotions, FDA oversight is expanding across every corner of the drug and digital health ecosystem. Our latest blog unpacks the key drivers behind this escalation and what manufacturers should prepare for heading into 2026. 📘 Read the full article here: www.emmainternational.com #Compliance #FDARegulations #CDER #DrugQuality #PharmaceuticalManufacturing #TelehealthRegulation #RegulatoryAffairs #EMMAInternational 5 Like Comment To view or add a comment, sign in Secure BioMed Evaluations 614 followers + Report this post

• U.S. Food and Drug Administration

  Topic Paragraphs FDA Accomplishments for the American People Image 5: See Complete List of FDA Reforms See Complete List of FDA Reforms Image 6: FDA Seizes 7-OH Opioids to Protect American Consumers FDA Seizes 7-OH Opioids to Protect American Consumers The U.S. Food and Drug Administration, in coordination with the U.S. Department of Justice, announced today that the U.S. Marshals Service seized approximately 73,000 units of 7-hydroxymitragynine (7-OH) products—valued at roughly $1 million—from three firms in Missouri. Read More Products We Regulate ### Food ### Drugs ### Medical Devices ### Radiation-Emitting Products ### Vaccines, Blood, and Biologics ### Animal and Veterinary ### Cosmetics ### Tobacco Products Report a Problem with an FDA Regulated Product [...] Image 7: Woman hiking on hilltop wearing sun glasses and sun hat for protection from the sun. ### FDA Encourages Development of New, Reliable Alternatives to Animal Testing in Sunscreen FDA strongly encourages companies to continue to develop new, reliable ways to minimize animal testing.Image 8: Photo of multi-generational family enjoying themselves outside. ### FDA Focuses on Closing the Clinical Trial Reporting Gap for Research Integrity The FDA is committed to ensuring data transparency by promoting timely registration and reporting of results information to ClinicalTrials.gov.Image 9: Image of female scientist staring at a highlighted pill, and a background of multiple charts and graphs with a Aqua green gradient. ### FDA Advances Drug Development Innovation by Establishing ISTAND as

• Food and Drug Administration: What to Watch in 2026 and Beyond

  ## Reauthorization of User Fee Agreements As the FDA embarks upon 2026, the agency must contend with many consequential policies, beginning with the reauthorization of various user fee agreements (UFAs). Several UFAs – including those for prescription drugs, biologics, medical devices, biosimilars and generic drugs – expire on September 30, 2027, and must be extended by statute. The statute provides legal authority for FDA to collect user fees from product applicants. It typically also contains reforms to FDA review processes. [...] ## Reducing Animal Testing The FDA in 2025 made changes to phase out the use of animal models and expand the use of real-world evidence, instituting a shift toward new approach methodologies and away from a requirement for identifiable individual data in certain drug and device application submissions. Both are efforts to accelerate product approvals and speed their ability to get to market. These efforts are anticipated to continue and hew closely to the FDA's Roadmap to Reducing Animal Testing in Preclinical Safety Studies that was published in April 2025. Stakeholders will continue to have opportunities to inform the guidance development process, with the FDA's guidance on real-world evidence recently being published in the Federal Register. ## Adoption of Artificial Intelligence [...] ## Over-the-Counter Monograph User Fee Act Implementation The appropriations bill that was signed into law on November 12, 2025, to reopen the federal government following the government shutdown included a reauthorization of the Over-the-Counter Monograph Drug User Fee Program (OMUFA) through September 2030. Congressional oversight activities are expected over the next several years to track OMFUA implementation. Also contained in the OMUFA reauthorization was a provision to reform the approval processes for sunscreen ingredients. Within a year, the FDA is tasked with issuing new guidance regarding how sponsors of active ingredients may use nonclinical testing alternatives to animal testing to meet safety and efficacy standards.

• Recent FDA Actions Pose Big Changes and Questions for Health ...

  Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and proposed regulatory changes that could dramatically impact the drug, biologics and food industries. Specifically, the FDA has: [...] Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and proposed regulatory changes that could dramatically impact the drug, biologics and food industries. Specifically, the FDA has published more than 200 complete letters that were issued in response to new drug applications and biologics license applications submitted for approval between 2020 and 2024; issued a statement "encouraging" manufacturers of baby food, infant formula and other food for children to work with FDA to "improve public awareness" about product recalls; and stated that the agency may fast-track new drugs from pharmaceutical companies that "equalize" the cost of their medicines between the U.S. and other countries. [...] 1. published more than 200 decision letters, known as "complete response letters" (CRLs), that were issued in response to new drug applications (NDAs) and biologics license applications (BLAs) submitted to the FDA for approval between 2020 and 2024 2. issued a statement "encouraging" manufacturers of baby food, infant formula and other food for children to work with FDA to "improve public awareness" about product recalls 3. stated that the agency may fast-track new drugs from pharmaceutical companies that "equalize" the cost of their medicines between the U.S. and other countries. These new policies, if finalized, could have significant implications for FDA-regulated industries. ## Complete Response Letters

• FDA Increases Flexibility on Requirements for Cell and Gene ...

  “Regulatory flexibility must be tailored for cell and gene therapies,” said FDA Commissioner Marty Makary, M.D., M.P.H. “These are common-sense reforms that will address the unique characteristics of cell and gene therapies and foster more innovation.” Over the last decade, the FDA’s Center for Biologics Evaluation and Research (CBER) has approved close to 50 CGTs. The transformative potential of these therapies has captured the imagination of the patient community and ignited product development. [...] 1. Press Announcements FDA News Release # FDA Increases Flexibility on Requirements for Cell and Gene Therapies to Advance Innovation For Immediate Release: The U.S. Food and Drug Administration today announced it is sharing information about the agency’s flexible approach to overseeing chemistry, manufacturing and control (CMC) requirements for cell and gene therapies (CGT). The agency’s more flexible approach has been, and is expected to continue to be, helpful in expediting product development and will help guide the FDA’s evaluation of development strategies in preparation for a Biologics License Application (BLA) submission.