Things to Know About...
Fast facts about FDA’s Center for Drug Evaluation and Research’s (CDER) efforts and actions
Latest Things to Know About...
9 Things to Know About Biosimilars and Interchangeable Biosimilars
FDA-approved biosimilars are safe and effective biologic medications that are highly similar to biologic medications already approved by FDA – called “reference products.” There are no clinically meaningful differences in safety, purity, or potency (safety and effectiveness) between biosimilars and their reference products.
10 Things to Know about CDER’s Pharmaceutical Quality Functions
Pharmaceutical quality is about more than just the quality of the drug itself. It includes the manufacturing facilities and the processes used to manufacture the drug. Some of CDER’s pharmaceutical quality functions occur before a prescription drug is approved and reaches patients.