Old Drugs, New Tricks: FDA’s Drug Repurposing Initiative
On May 11, 2026 the FDA launched a public docket (FDA-2026-N-4492) to gather stakeholder input on its new drug‑repurposing initiative, inviting comments by June 11, 2026. The agency seeks guidance on priority chronic disease areas and on which already‑approved drugs have the strongest potential for new indications. It frames the request around three evidence tiers—well‑controlled data, preliminary clinical signals, and pre‑clinical hypotheses—and highlights existing tools such as BPCA, the MODERN Act, Project Renewal, and the ID platform. The move aligns with similar EU pilots and the White House’s MAHA strategy to address unmet medical needs through repurposing.
One Day at a Time: FDA’s New AI-Informed Inspection Pilot and What It Means for Industry
The FDA launched a pilot on May 6 2026 to conduct one‑day inspectional assessments of facilities flagged as low‑risk by artificial‑intelligence models. By late April, roughly 46 such inspections had been completed, most ending with a “No Action Indicated” outcome, though inspectors...
“Sounds Great. Do You Want FDA Approval?” A Regulatory Analysis of Psychedelics
On April 18, 2026 President Trump signed an executive order compelling the FDA to prioritize review of psychedelic drugs, issuing priority‑review vouchers for three compounds already holding Breakthrough Therapy designation. The order also creates a Right‑to‑Try pathway for ibogaine, directs...
Drug Amount Reporting: FDA Publicly Identifies over 7,700 Noncompliant Companies
On March 31 2026 the FDA released a public list showing that more than 7,700 drug manufacturers failed to submit the required 2024 drug‑amount reports. The list separates 1,254 firms with active drug listings from 6,480 firms with inactive listings, highlighting a...
FDA-Approved Marijuana Products and Those Subject to State-Issued Licenses Rescheduled; Marijuana Hearing Calendared; Dispensary Applications Accepted
Acting Attorney General Todd Blanche and the DEA issued a final rule that instantly reschedules FDA‑approved THC drug products and marijuana sold under state medical licenses from Schedule I to Schedule III of the Controlled Substances Act. The rule aligns federal regulation...
CRL Release Update – No Litigation War yet, but New Citizen Petition Beats the Drums
The FDA has begun posting Complete Response Letters (CRLs) for unapproved NDAs, ANDAs, and BLAs, releasing 127 documents to date, including 36 that had never been publicly disclosed. A Washington‑based law firm filed a Citizen Petition on April 20, 2026,...
Results May Vary, But Reporting Shouldn’t: FDA Sends a Not-So-Gentle Reminder on ClinicalTrials.gov Compliance
On March 30, 2026, the FDA emailed more than 2,200 sponsors and investigators linked to over 3,000 clinical trials that have not posted required results on ClinicalTrials.gov or failed quality‑control review. The agency reminded that results must be posted within...
What Does DOJ’s New Corporate Enforcement Policy Mean for the FDA- and DEA-Regulated Industry?
The Department of Justice released its first department‑wide Corporate Enforcement and Voluntary Self‑Disclosure Policy (CEP), establishing a uniform framework for prosecuting corporate crime. The policy lets companies obtain a declination of charges if they voluntarily disclose misconduct, fully cooperate, remediate...
Enough Will They-Won’t They! FDA Pushes for Permanent Rare Pediatric Disease PRVs
The FDA’s FY2027 budget request asks Congress to make the Rare Pediatric Disease (RPD) Priority Review Voucher program permanent, ending its four‑year reauthorization cycle. A voucher lets sponsors shave FDA’s review time from ten to six months and can be...
FDA Looks East—Here’s What Industry Needs to Know
The FDA’s FY2027 budget proposes $2.5 million and five new full‑time staff to open foreign offices in Hanoi, Vietnam, and Tokyo, Japan, expanding its inspection footprint in East Asia. The request follows FY2026 congressional language urging permanent presence for unannounced inspections...
FDA Launches READI-Home Innovation Challenge: Opportunities—And Tensions—For Home-Use Device Developers
On April 7, 2026 the FDA’s Center for Devices and Radiological Health launched the READI‑Home Innovation Challenge, a two‑phase program aimed at accelerating home‑use medical devices that can cut hospital readmissions. Developers submit a 16‑page Q‑Submission by September 30, after which up...
FDA’s Fiscal Year 2027 Budget Is Chock-Full of Legislative Proposals – Especially on Hatch-Waxman and the BPCIA
The FDA’s FY2027 budget request bundles 27 legislative proposals into its Justification of Estimates for Appropriations Committees, a sharp increase from prior years. Highlights include allowing U.S. generic manufacturers to file Paragraph IV certifications a month earlier, deeming all approved...
Bipartisan Push for FDA “Pre-Review” Of DTC Drug Ads
On March 31, 2026 Senators Dick Durbin and Roger Marshall sent a bipartisan letter urging the FDA to require pre‑submission of certain direct‑to‑consumer (DTC) prescription‑drug television ads. The request builds on earlier concerns about the FDA’s limited enforcement capacity despite...
HPM Seeks a Junior to Mid-Level Associate With Healthcare Experience
Hyman, Phelps & McNamara (HPM), a leading boutique FDA regulatory law firm, announced a search for a junior‑to‑mid‑level associate with two to five years of healthcare compliance experience. The role will advise pharmaceutical, biotech, and medical‑device clients on antikickback statutes,...
Job Opportunity: HPM Seeks Associate Drug Development Attorney
Hyman, Phelps & McNamara (HPM) announced a vacancy for a 3rd‑to‑6th year associate attorney on its drug development team. The role supports clients through the full FDA pre‑market lifecycle, from pre‑IND strategy to IND, NDA/BLA submissions and dispute resolution. Candidates...