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...
7 Things to Know About How You Can Find CDER’s Drug Safety Information
In this Internet Age, we often go online for medical and health-related information. But not all this information is reliable, including information about medications. There are many false statements and conclusions shared online. Making medical decisions based on inaccurate information can lead you to choose drugs that are not safe and effective.
7 Things to Know About the Nonprescription Drug Product with an Additional Condition for Nonprescription Use Final Rule
FDA’s Center for Drug Evaluation and Research (CDER) has finalized the rule, Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU). The rule is intended to increase options for drug companies to develop and market safe and effective nonprescription drugs, which are drugs that consumers can buy without a prescription. This rule has the potential to increase the types of drugs available to you without a prescription from your health care professional.
7 Things to Know About Drug Shortage Management
We know it can be frustrating when you can’t get a medicine you need. That’s why FDA works closely with the pharmaceutical industry and other stakeholders to prevent drug shortages and to lessen the impact on patients any time there is a delay in the availability of the medicines you need. Ensuring access to safe, effective, high-quality medicines is one of our top priorities.
9 Things to Know About CDER’s Efforts on Rare Diseases
CDER understands there are unique challenges in demonstrating the safety and effectiveness of drugs that treat rare diseases. Here are some things to know about CDER’s efforts to accelerate the development of safe and effective drugs to treat rare diseases and conditions.
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.