The FDA’s Center for Drug Evaluation and Research (CDER) is responsible for reviewing and approving both prescription and nonprescription or over-the-counter (OTC) drugs.
To introduce a new drug product into the U.S. market, some firms submit a new drug application (NDA) to the US FDA/CDER.
The firms are responsible for testing a drug and for submitting evidence that the drug is safe and effective.
This webinar is intended to help you better understand FDA’s drug review and approval process. The FDA’s recent approvals of novel drugs will also be discussed.