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

The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald ...

Takeaways from the AP’s report on turmoil surrounding the FDA’s new fast-track drug program

Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on ...

Exclusive-US FDA delays two drug reviews in new voucher program after safety, efficacy concerns

By Patrick Wingrove Jan 15 (Reuters) - The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the ...
JD Supra

340B Drug Pricing Program Is on a Slippery Slope

On July 31, 2025, notice was published in the Federal Register by the Health Resources and Services Administration (“HRSA”) of a “340B Rebate Model Pilot Program” (“340B Pilot Program”). The 340B ...

S.F. ramps up program to compel drug users into treatment. Critics say it doesn't work

The city said 100 people lost welfare benefits for not complying with treatment last year, although flexible requirements ...
Becker's Hospital Review

FDA delays 2 drug reviews in priority voucher program

FDA delays drug reviews for two priority voucher drugs amid safety and efficacy concerns, extending timelines for Sanofi and Disc Medicine products.
JD Supra

OIG Deems Free Drug Patient Assistance Program Low-Risk in Advisory Opinion 25-01

On January 15, 2025, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 25-01, a favorable opinion analyzing a pharmaceutical manufacturer’s ...