Manufacturers

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.

In contributed commentary, Susan Levy, SBL Consulting Group founder and principal, discusses likely health and wellness market developments which would reflect a steady shift toward more accessible, consumer-centric models of care complementing traditional healthcare.

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

Wonderbelly reached market in 2022 and has notched nationwide footprint through major retailers over the years, Target stores starting in March 2023, CVS since June 2024 and Walmart since May 2025.

The leading Japanese generics player and local originator will collaborate on technology transfer, contract manufacturing and product succession as part of a cross-sector effort to strengthen supply chains for long-listed and off-patent medicines.

Industry trade group executives discuss two central questions: What trends, challenges, or opportunities do you expect will define the industry in 2026? Did developments you anticipated materialize?

In PDUFA reauthorization subgroup meetings, CHPA suggests expanding FDA’s special protocol assessment program to include OTC drug studies before FDA notes Congress has required it to provide switch-specific guidance before current PDUFA expires.

FDA rejects petition asking for approval to use, as health claims for supplements, nutrient–disease statements drawn directly from government publications and public-facing materials produced by NIH, CDC and other federal health agencies.

A pair of private equity mega-deals dominated the mergers and acquisitions landscape in 2025, but there was still a clear appetite for smaller, strategic takeovers and tuck-ins across the generics, biosimilars, and off-patent medicines field.

“There's a lot of third-party audit information out there. Could we take that and apply it into our inspectional planning process?” says Office of Dietary Supplement Programs Director Cara Welch.

Civica has been cleared to supply essential generic medicines across the US veterans health system under a federal supply schedule agreement.

A Delhi High Court has declined Novo Nordisk’s bid to halt Reddy’s ongoing production, allowing exports while patent validity proceeds to trial.