Supply Chain

FDA says Teresa Michele, in CDER nonprescription drugs program leadership roles since 2013, was being moved to another position in the agency.

CRN’s attorneys ask Second Circuit for en banc review of a three-judge panel’s denial of its appeal of 2024 decision in district court rejecting motion for preliminary injunction against enforcement of New York state law age-restricting sales of weight loss and muscle building supplements.

Pazdur’s departure just weeks into the job creates more uncertainty for the biopharma industry and an embarrassing situation for Commissioner Martin Makary, who personally lobbied him to take the position.

Agency intends to use information from comments to guide its planning for a public meeting during 2026, according to a Federal Register notice. A GAO report is due in a year to Congress profiling FDA’s progress on making more drugs available nonprescription through OTC switch applications.

CRDMOs, CDMOs and GCCs are driving partnering and invigorating the wider ecosystem as India moves up the innovation value chain. CRDMOs are moving well beyond traditional outsourcing roles, a new report shows.

Lawmakers in IL, MA and NJ as well as MI consider proposals as firms marketing weight loss and bodybuilding supplements in New York already are subject to first-ever state law limiting sales of products to consumers 18 and older.

Approval of numerous Rx formulations hasn’t translated to wider availability when a remedy is needed for anaphylaxis emergency, say FDA and the Margolis Institute in announcing workshop on reducing anaphylaxis-related morbidity and mortality.

Canadian firm states in 2026 forecast that its research, including consumer surveys and sales data, shows a majority of consumers, 65%, are not only familiar with the benefits of prebiotics but also interested in the ingredients, 55%.

Regardless of THC level and even though the US hemp product marketplace is growing, FDA regulations prohibit the botanical’s use as a dietary ingredient or food additive because it’s been studied or approved for use as a drug in the US.

OMUFA reauthorization and directions for FDA to provide reports on monograph program and guidance on improving chances for OTC switch applications included in recent stopgap spending bill to end federal government shutdown.

After using supplements from third-party providers for personalized nutrition programs it offered to patients at wellness clinics it operated, Designs for Health has shifted to focus entirely on providing supplements to healthcare practitioners.

Three-judge Second Circuit panel rejects CRN’s argument that New York General Business Law Section 391-oo, effective since April 2024 as first in US to prohibit sales of certain supplements to consumers under 18, violates First Amendment rights of supplement marketers.