FDA

The FDA wants to waive facility fees for three years if a sponsor breaks ground on a US-based manufacturing plant, but industry is concerned the idea will force other sponsors to subsidize competition.

Agency exercises enforcement discretion on requirement for products to be labeled as containing artificial colors or dyes when those aren’t native to foods or ingredients, including added colors made from natural sources.

“Dietary Supplement Regulatory Uniformity Act” would prohibit states from adding requirements and rules for supplement manufacturing and sales on top of FDA regulations.

The clinical and statistical review teams favored a complete response letter for the vasculitis treatment, while the review division and office directors supported approval.

Investors appeared not to be bothered by Amgen’s Q4 product updates, including the US FDA’s request to pull rare disease drug Tavneos from the market and discontinuation of Phase III bemarituzumab.

Transpire Bio continues to advance its complex generics franchise, with another Paragraph IV filing for GSK’s Ellipta portfolio inhaler.

“FDA’s proposed GRAS rule would move GRAS closer to the NDI model in at least one key respect, which is mandatory notification,” says attorney Ashish Talati. Proposed rule isn’t expected to require removal of ingredients available through self-GRAS processes.

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.