Fierce Biotech

CBER chief Prasad steps aside, deputy takes the reins as search for successor continues

As the calendar turned from April to May, a big change came to the FDA. | Katherine Szarama, Ph.D., will take over as CBER ...
JD Supra

FDA Launches Support for Clinical Trials Advancing Rare Disease Therapeutics (START) Pilot Program

On May 31, 2024, the FDA announced initiation of the Support for Clinical Trials Advancing Rare Disease Therapeutics (“START”) pilot program. The START program, led by the Center for Biologics ...
Hosted on MSN

FDA and EMA unveil stricter biologics compliance agendas

The FDA and EMA have set out updated regulatory agendas that will shape biologics manufacturing standards in coming years. The FDA’s Center for Biologics Evaluation and Research (CBER) 2026 agenda ...
RAPS

CBER chief says pilot program will justify increasing reviewer headcount

Cell and gene therapy manufacturers may not like the idea of spending more money on US Food and Drug Administration (FDA) reviewers, but a top official said if a new pilot project goes according to ...
RAPS

CBER Unveils New Electronic Reporting System for Vaccine Adverse Events

The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Thursday announced the availability of an electronic submission system for companies to submit ...