The stated purpose of the open public meeting was to solicit specific, actionable policy suggestions for the review staff of the FDA’s Center for Drug Evaluation and Research (CDER), Office of ...

CDER Office of Drug Product Promotion director Tom Abrams told a Drug Information Association annual meeting session in June. FDA’s Brief Summary guidance is being re-worked, he said, “based on data ...

C3TI is governed by various offices of CDER, including the Office of the Center Director, the Office of Communications, the Office of Compliance, the Office of Medical Policy, the Office of New ...

The FDA’s Center for Drug Evaluation and Research (CDER) is consolidating its artificial ... offer a consistent voice in the drug center’s communications to the public and the industry on ...

In January 2024, the Office of Compliance at the FDA’s Center for Drug Evaluation Research (CDER) released its Annual Report for FY2023. The Annual Report contains several useful pieces of ...

Lawrence Yu, Deputy Director, Office of Pharmaceutical Quality at FDA’s Center for Drug Evaluation and Research (CDER), shares insights with Pharmaceutical ... technology, and communication, covering ...

That responsibility will move to a new division in the CDER’s Office of Cardiology ... management, and communication of safety information across development programs and throughout the pre ...

The report cites a new trend in an increase in communications ... trend from previous years. The CDER Ombudsman is an independent public official that works to informally resolve questions, complaints ...

M.D., former Director of the Office of New Drugs for the FDA’s Center for Drug Evaluation and Research (CDER); Robert Meyer, M.D., former Director of CDER’s Office of Drug Evaluation II ...

Billy Dunn is director of CDER’s Office of Neuroscience. Peter Stein is director of CDER’s Office of New Drugs. Earlier this month, the Food and Drug Administration approved aducanumab (under ...

Spoiler alert: The clear takeaway from the meeting is that the hub will succeed only if everyone involved prioritizes better internal and external communications.