Article Summary:
This week, the US Department of Health and Human Services (HHS) announced the end of research using aborted human fetal tissue and the US withdrawal from the World Health Organization (WHO). HHS cited ethical concerns and mishandling of the COVID-19 pandemic as reasons for these decisions.
In an effort to strengthen the domestic pharmaceutical supply chain, the FDA is launching a PreCheck Pilot Program to streamline oversight and encourage domestic manufacturing. The FDA also published its annual report on new drug approvals, highlighting that 46 novel drugs were approved in 2025, with 33 utilizing expedited programs. Additionally, 18 biosimilars were approved, including 4 for new reference products.
The FDA is seeking public input on improving labeling and cross-contamination information related to gluten in food products. The agency also provided an initial review of the FDA ImportShield Program, which has led to faster processing, increased capacity, and reduced staff hours for regulated import products.
In the drugs and biologics sector, the FDA and the generic drugs industry discussed several issues during the Generic Drug User Fee Amendments (GDUFA III) negotiations. Additionally, Valneva has decided to withdraw its applications for its chikungunya vaccine, Ixchiq, in the US due to a suspension and clinical hold.
The Reagan-Udall Foundation for the FDA will host a public meeting on reducing reliance on animal testing in drug development. The FDA also issued early alerts for two medical device products: Integra LifeSciences’ MediHoney Wound and Burn products and Olympus’ High Flow Insufflation Units, citing packaging and software issues, respectively.