FDA

Regulatory streamlining represents a paradigm shift for the biosimilars industry, but does it go far enough? Gillian Woollett, Samsung Bioepis’ head of regulatory strategy and policy, says streamlining must be accompanied by a sustainable economic environment for biosimilars to ensure global access.

Changing self-GRAS regulation, providing NDIN safety and identity guidance and modernizing supplement industry regulatory framework are on FDA’s “2026 priority deliverables,” but not requirement for public listing of all supplements available.

The company said the FDA placed the hold on RGX-111 and RGX-121 after a patient in its RGX-111 trials developed a brain tumor, the cause of which remains under investigation.

Responding to recent FDA guidance on a new streamlined pathway for US biosimilars, off-patent industry representatives have urged the agency to make the approach “the new default” for biosimilar filings. However, PhRMA has suggested limiting the route to less complex product types.

When FDA warned Agebox about selling iKids-Growth IGF-1 Support supplements as unapproved drugs, agency along with CDC had for around a month been investigating outbreak of infant botulism linked to ByHeart formula.

FDA Human Foods Program’s list notes Kennedy’s GRAS focus as first item in “Food Chemical Safety” category, saying the agency in 2026 “will publish a proposed regulation to require the submission to FDA of GRAS notices for all substances claimed to be GRAS.”

Lawsuit filed in District of Columba federal court alleges FDA violated the authoritative statement provisions of FD&C Act, Constitutional Avoidance Doctrine and First Amendment by rejecting ANH-USA’s petition to allow 114 science-based health claims sourced directly from federal agencies.

Generics Bulletin reviews global regulatory developments across the world.

FDA updates pair of guidance documents relaxing its posture on how it regulates general wellness devices and clinical support software. Industry mostly welcomes changes, agreeing with agency’s view that lighter regulation will help spur innovation.

Consumer health product industry regulatory experts discuss two central questions: What trends, challenges, or opportunities do you expect will define the industry in 2026? Did developments you anticipated materialize?

CRN’s support, a pivot from qualified backing for the previous bill, came after the senator added language to relieve firms of some responsibility around providing all claims for their products to FDA to include public-facing list.

Speaking at a pre-J.P Morgan science summit, Sarah Yim – director of the US FDA’s Office of Therapeutic Biologics and Biosimilars – set out the FDA’s plans to achieve further progress on biosimilars both domestically and internationally in 2026.