Agency is painting the new advice program as an attractive, ‘all-hands-on-deck’ option for sponsors beginning an RWE program for a new indication or a post-marketing commitment. With the first two slots filled, the next opportunity for sponsors has an end-of-September deadline.
The US Food & Drug Administration is portraying its new “Advance Real-World Evidence” advice program as an attractive pathway for sponsors hoping to pursue new indications or to fulfill post-marketing commitments using non-traditional, “real world” data.
During a 6 June session of the annual FDA Regulatory Education for Industry (REdI) conference, the agency’s Kimberly Smith was...
The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.
The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.
Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.
The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.
