Young US FDA Office Of New Drug Policy Faces Regulatory Crucible In COVID-19
Created last year under the Office of New Drugs reorganization, ONDP works to promote regulatory consistency while fostering innovation – and reacting to unexpected challenges like the pandemic.
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CBER’s New Home For Gene Therapies: OTAT Changes To OTP But Leadership Questions Remain
US FDA has not named permanent heads of several offices within the new Office of Therapeutic Products, the only super office in the Center for Biologics Evaluation and Research.
CBER Designing Triage System For Gene Therapy Submissions In Lieu Of ‘First In, First Out’ System
Ideally, the system will prevent some cell and gene therapy programs from slowing, CBER Director Peter Marks says.
US FDA Integrated Assessment Roll-Out Expanding By End Of 2021
All NMEs and original BLAs are expected to adhere to the team-based review approach by the end of the year, with expansion to other application types later.