FDA

A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.

In a somewhat surprising move, president Donald Trump’s Federal Trade Commission carries the torch in a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon told Generics Bulletin what it means for the generic drug industry.

A weak second half in Glenmark’s India business during the firm’s 2025 financial year took the gloss off its earnings somewhat for the year. However, Glenmark is plotting several avenues to return to growth, in both of its core business regions: India and the US.

Marking most strident use of authorities it received in 2020 as part of an overhaul of monograph system, FDA publishes proposal to shift orally disintegrating formats to individual-dose packaging and a related proposal to minimize firms’ regulatory burden for making delivery format changes potential

HELP members state frustration with layoffs at FDA and pose questions about topics from generic drug approvals to OTC switches, and from manufacturing location labeling to whether the federal agencies intrude on US consumers. Still, acting CDER director Jacqueline Corrigan-Curay makes clear the resu

Results of survey found a majority of representative sample of US voters nationwide agree “current regulations should be updated and strengthened to protect consumers,” CHPA says.

Discussion of the administration’s “Make America Healthy Again” campaign at a recent regulatory conference provided a platform for questions about what HHS Secretary Kennedy wants and how he expects to get there.

After half a year of silence, the US FDA has published 48 product-specific guidances for generic development. With critical staff laid off, will the health agency stick to its updated PSG publishing schedule?

In a nod to drug manufacturers’ potential interest in moving to natural alternatives for petroleum-based synthetic dyes the agency intends to remove from use, document explains process for asking for approval for “any dye, pigment, or other substance that can impart color to a food, drug, cosmetic,

Effective date for ACNU OTC switch final rule and finding of severe itching from long-term use of common allergy ingredients are bookends for limits of FDA’s authority for product label changes.

Bridget Dooling, law school professor who reviewed draft regulations from FDA and other agencies as OMB attorney, says history of federal court decisions in litigation challenging FDA’s interpretation of statutes points to judges typically defer to agency decisions based in science.

Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.