FDA’s OTP Town Hall Clarifies CMC and Facility Readiness Standards for Gene Therapy BLAs
The FDA’s Office of Therapeutic Products (OTP) within the Center for Biologics Evaluation and Research (CBER) hosted its Virtual...
FDA’s 2025 Roadmap for Generics: Modernizing Policy, Transparency, and Global Alignment
At the Advancing Generics 2025 forum, FDA officials, policy leaders, and industry executives outlined the next phase of the...