Day: February 9, 2023

All submissions made to the FDA by an organization are reviewed and tallied to previous submissions made by the same organization, person, locations and other identifiers. The FDA keeps track of all submissions and any deficiencies identified are tracked as well to assure that non-compliance is addressed. Occasionally events happen that demonstrate this fact. Between … Read more

In its fifth annual report, FDA’s Oncology Center for Excellence (OCE) listed its expectations for modernizing oncology clinical trials. In its sixth year of operations, the OCE wants to move beyond the work it has accomplished so far and focus on patient and physician perspectives for oncology drugs in clinical trials or available currently in … Read more