U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

  1. Home
  2. Drugs
  3. News & Events for Human Drugs
  4. Things to Know About...
  1. News & Events for Human Drugs

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 Drug Shortage Management

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.

Read more


Rare Disease

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.

Read more


Woman consulting with physician about biosimilars

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.

Read more


elderly woman speaking to a pharmacist about pharmaceutical quality.

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. 

Read more


 



Back to Top