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 of food, drugs, devices, and aquaculture products. Hanoi targets Vietnam’s rapidly growing medical‑device and drug imports, which have risen tenfold since 2015, while Tokyo serves as a regional hub and deepens U.S.–Japan regulatory collaboration. Operational rollout may be delayed by staffing and security‑clearance challenges.
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...
DEA Fine Tunes Power of Attorney and DEA-222 Requirements
On March 20, 2026, the DEA issued a technical amendment to its 2019 final rule that clarifies who may execute and revoke Power of Attorney documents for DEA Form 222 and who may sign the form itself. The amendment aligns...
FDA Signals Potential Updates to SUPAC Guidances—Comments Due June 1, 2026
The FDA has opened a public docket to solicit comments on its long‑standing Scale‑Up and Post‑Approval Changes (SUPAC) guidances for immediate‑release solid oral, non‑sterile semisolid, modified‑release solid oral dosage forms and the manufacturing equipment addendum. The agency seeks feedback on...
Surprise! Fifth Circuit Rejects DEA’s Longstanding Interpretation of a Pharmacist’s “Corresponding Responsibility” And “Usual Course of Professional Practice” Regulations
The Fifth Circuit rejected the DEA’s long‑standing reading of the pharmacist’s “corresponding responsibility” and “usual course of professional practice” regulations, ruling that liability requires proof a prescription was invalid when issued and that the pharmacist actually knew it was invalid....
The Government’s Warning Shot? FDA and HHS Turn Up the Pressure on Compounding
The FDA, backed by HHS, issued a stark warning to compounding pharmacies that market GLP‑1 products such as semaglutide, after Hims & Hers promoted a compounded Wegovy copy. A press release announced intent to restrict non‑approved GLP‑1 APIs and referred...
Rare Disease Month Developments – Part 3: The Ugly (Just Kidding) – See You at Rare Disease Week
Rare Disease Week convenes on Capitol Hill, bringing patients, advocates, regulators, and industry together to shape policy for rare disease therapies. Hyman, Phelps & McNamara will be prominently represented, highlighted by Frank Sasinowski receiving the EveryLife Foundation’s Abbey Lifetime Achievement...
Rare Disease Month Developments, Part 1 – The Good: RPD PRV Program Renewed, FDA Rare Disease Hub’s 2026 Strategic Agenda...
Congress renewed the Rare Pediatric Disease Priority Review Voucher (RPD PRV) program, extending it to September 30 2029 and eliminating the dual sunset dates. The FDA released its Rare Disease Innovation Hub’s 2026 Strategic Agenda, allocating $1 million in funding and outlining plans...
Who Qualifies for the New FDA PreCheck Pilot Program?
The FDA has opened submissions for its PreCheck Pilot Program, targeting new U.S. drug‑manufacturing facilities that will begin construction by the March 1 2026 deadline. Eligible sites must be stand‑alone plants, located in the United States or its territories, and commit to...
Can a Citizen Petition Denial Turn a Warning Letter Into Final Agency Action? The Curious Case of Hybrid Pharma
The Southern District of Florida held that a denial of a citizen petition transforms the underlying FDA warning letters into final agency action, allowing judicial review. Hybrid Pharma sued after the FDA refused to rescind two warning letters and the...
ACI’s 22nd Annual Paragraph IV Disputes: Elevate Your 2026 Hatch-Waxman Strategy
The American Conference Institute will host its 22nd Annual Paragraph IV Disputes Conference on April 21‑22, 2026 in New York’s Times Center. The two‑day forum gathers brand‑name and generic drug stakeholders to discuss Hatch‑Waxman litigation strategies, recent case law, and evolving PTAB practices. Featured...
