Newsletter - February 9, 2023
FDA Remembers All Submissions: New Jersey Clinic Learned this Lesson
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...Read More
FDA Lists Four Expectations from Oncology Drug Developers
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...Read More
FDA Remembers All Submissions: New Jersey Clinic Learned this Lesson
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...Read More
FDA Lists Four Expectations from Oncology Drug Developers
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...Read More
