What are FDA guidance documents?

For more information, see: Guidance documents represent the Agency's current thinking on a particular subject. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.

How many FDA approvals are there in 2024?

The FDA kicked off 2024 with a bang. Between advances in immunotherapy, targeted therapy, and chemotherapy, the FDA issued 14 approvals for cancer indications from January through March. The slate of new indications includes four accelerated approvals, three conversions from accelerated to full approvals, and seven new full approvals.

What is the oncology center of Excellence?

OUR MISSION: The mission of the Oncology Center of Excellence is to achieve patient-centered regulatory decision-making through innovation and collaboration. OUR VISION: We seek to create a unified and collaborative scientific environment to advance the development and regulation of oncology products for patients with cancer.