On March 6, 2024, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) in combination with cisplatin and gemcitabine for first-line treatment of adult […]

Reports Mandated by FDORA The Food and Drug Omnibus Reform Act of 2022 (FDORA) requires FDA to develop several different kinds of informational documents, including public […]

UPDATE: On March 20, 2023, the FDA announced the withdrawal (revocation) of the biologics license for BLENREP indicated for the treatment of adult patients with relapsed or […]

Criteria to Participate in the Emerging Technology Program To qualify for participation in the Emerging Technology Program, technologies need to: Have the potential to improve product […]

Benefits to participating in the Emerging Technology Program. Participants in the program can expect: Pre-submission face-to-face interactions with ETT members and review staff to answer technical […]

The Emerging Technology Program serves as an entry point for new technologies that will potentially be included in a regulatory filing for a specific drug product. […]

FDA recognizes that adopting innovative approaches to manufacturing may present both technical and regulatory challenges. Pharmaceutical companies may have concerns that developing such technologies could result […]

FDA recognizes that adopting innovative approaches to manufacturing may present both technical and regulatory challenges. Pharmaceutical companies may have concerns that developing such technologies could result […]

The Emerging Technology Program serves as an entry point for new technologies that will potentially be included in a regulatory filing for a specific drug product. […]