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Apr 30, 2026
FDA issued guidance on the Food Traceability Rule, finalized an exemption for IMS-listed Grade A cottage cheese, and announced a June 15, 2026 public meeting on lot-level traceability, as Congress bars enforcement funding until July 20, 2028.
Apr 14, 2026
The Consolidated Appropriations Act, 2026 extends the FDA’s rare pediatric disease priority review voucher authority through Sept. 30, 2029. The law also requires a GAO report on the program’s effectiveness.
Apr 11, 2026
Q1 2026 sleep medicine trends include broader use of AI, expanding obstructive sleep apnea and narcolepsy treatments, and policy changes affecting reimbursement and access.
Apr 02, 2026
The FDA will drop its longtime requirement for two rigorous studies to approve new drugs, moving to a default position of requiring only one study. Commissioner Marty Makary says the change reflects modern scientific advances and aims to accelerate drug availability without compromising safety. The shift follows decades of increasing flexibility for rare and fatal diseases, with about 60% of first-of-a-kind drugs already approved based on single studies in recent years.
Mar 26, 2026
NIH funding uncertainty persists despite Congress rejecting budget cuts, with delays in grant dispersal and review processes creating challenges for biomedical researchers. The number of R01 grants dropped significantly from 2024 to 2025, and funding rates for both early-career and established researchers declined. Researchers face compressed timelines and administrative burdens that threaten scientific progress.
Mar 25, 2026
NIH has obligated only 15% of its $38 billion budget halfway through the fiscal year, causing universities to cut PhD admissions and implement hiring freezes. Early-career scientists face declining grant success rates despite increased applications. Congress recently reversed proposed 40% NIH budget cuts that had threatened research facility construction.
Mar 14, 2026
The Consolidated Appropriations Act, 2026, enacted February 3, reauthorizes the rare pediatric disease priority review voucher program through 2029, clarifies orphan drug exclusivity scope, and mandates increased transparency in FDA's generic drug determinations.
Mar 11, 2026
The Consolidated Appropriations Act, 2026 enacted February 3 narrows orphan drug exclusivity to specific approved uses rather than entire disease categories, overriding a 2021 court decision and codifying FDA's longstanding interpretation.
Feb 19, 2026
The FDA announced it will generally require only one pivotal trial for drug approvals, ending the decades-old two-trial standard. The policy aims to reduce development costs and speed market access while maintaining focus on trial quality.
Feb 19, 2026
The FDA will host Rare Disease Day 2026 on February 23, focusing on patient engagement and accelerating treatment development. The agency released its 2026 Strategic Agenda for the Rare Disease Hub, outlining new regulatory pathways and coordination efforts.
Feb 18, 2026
FDA Commissioner Marty Makary outlined plans to expand over-the-counter drug access, crack down on unlawful GLP-1 compounding, and address the U.S. falling behind China in early-stage drug development.
Feb 13, 2026
Congress enacted legislation narrowing orphan drug exclusivity to specific approved uses rather than entire diseases, overriding an 11th Circuit ruling and aligning the statute with FDA's traditional approach.
