Fierce Healthcare

CMS, FDA announce new program to speed up Medicare coverage of breakthrough medical devices

The Centers for Medicare and Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) announced on Thursday the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway for FDA-designated Class II and Class III breakthrough devices.
Hosted on MSN

FDA launches fast-track review vouchers for psychedelic drugs

The FDA has introduced a pilot program granting Commissioner’s National Priority Vouchers to three psychedelic therapy programs, aiming to cut review times from up to a year to as little as one month after application submission. The move follows a ...

FDA Approves First-Ever Gene Therapy for Treatment of Genetic Hearing Loss Under National Priority Voucher Program

The U.S. Food and Drug Administration today approved Otarmeni (lunsotogene parvec-cwha), the first-ever dual adeno-associated virus (AAV) vector-based gene therapy. Otarmeni is indicated for the treatment of pediatric and adult patients with severe-to-profound and profound sensorineural hearing loss (any frequency >90 dB HL) associated with molecularly confirmed biallelic variants in the OTOF gene.
Yahoo

Legal questions swirl around FDA's new expedited drug program, including who should sign off

WASHINGTON (AP) — The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald Trump's administration is causing alarm across the agency, stoking worries that the plan may run afoul of ...

MAHA school lunch program seeing ‘impressive results’ tackling ultra-processed foods, says FDA head

Lunch ladies are getting a MAHA makeover. The Food and Drug Administration’s $17 million pilot program aimed at helping schools serve MAHA-approved meals to students is up and running — and already reportedly seeing results.
JD Supra

FDA Expands Early Alert Program to All Medical Devices

On September 29, 2025, the U.S. Food and Drug Administration (FDA) announced the expansion of its Early Alert program to include all medical devices. This expansion builds on a pilot program that introduced Early Alerts for medical devices in only five ...
Truckinginfo

FDA Program Will Put More RFID Tags in the Freight Stream

The Food and Drug Administration Monday announced an initiative to encourage the use of RFID by drug companies. Phillips Industries’ new Cincinnati-area distribution center is now shipping aftermarket trucking parts nationwide, aiming to speed up ...
RAPS

Study: FDA’s expedited programs play increasing role in bringing novel drugs to market

Expedited development and review programs established by the US Food and Drug Administration (FDA) have a growing role in bringing drugs and biologics to market, with novel orphan and nonorphan products using expedited programs alone in combination to ...
JD Supra

New FDA Program Prioritizes Review of Certain ANDAs

On October 3, 2025, the U.S. Food and Drug Administration (FDA) unveiled a pilot prioritization program that provides for accelerated review of abbreviated new drug applications (ANDAs) for generic companies that test and manufacture their products in the ...