RAPS

FDA issues draft guidance on reporting manufacturing changes for gene therapies

The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Friday issued a guidance to assist sponsors of cell and gene therapies (CGTs) in determining whether ...
BioProcess International

Integrating Quality by Design Principles into Gene-Therapy CMC Programs: Establishing Manufacturing Control and Comparability

Quality by design is critical for cell and gene therapy manufacturing where process controls directly influence product ...
RAPS

FDA finalizes neurodegenerative disease gene therapy guidance

The US Food and Drug Administration (FDA) last week finalized guidance to assist sponsors developing human gene therapy (GT) products for neurodegenerative diseases. In the final version, FDA acceded ...
JD Supra

FDA rethinks need for comparative efficacy studies for certain biosimilars

The U.S. Food and Drug Administration (FDA) issued new draft guidance on October 29, 2025, proposing what it said were “major updates to simplify biosimilarity studies and reduce unnecessary clinical ...