April 18th 2025
The recombinant vaccine, under the brand name Vimkunya, is recommended for persons age 12 and older who are traveling to a country or territory where there is a chikungunya outbreak.
The digital transformation of quality-by-design assessment workflows can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
EMA Recommends Imfinzi-Based Perioperative Regimen for Treating Resectable NSCLC
March 10th 2025The committee’s recommendation is based on results from a Phase III trial in which Imfinzi demonstrated a reduced risk of recurrence, progression, or death by 32% compared to neoadjuvant chemotherapy alone.