Innovation at FDA
Helping to Speed Cures and Treatments to Patients
The U.S. Food and Drug Administration is committed to helping deliver innovative, safe, and effective treatments and cures to the patients who need them as quickly as possible. To achieve this goal, we have implemented a variety of expedited review programs and are working to help shorten the development time before a product is even submitted for FDA review.
Accomplishments: Drugs
As a result of these efforts, in 2014 alone, FDA approved 51 new molecular entities and biological products (41 by our Center for Drug Evaluation and Research and 10 by our Center for Biological Evaluation and Research). These approvals included major therapeutic advances in the treatment of cancer, hepatitis C and type-2 diabetes. They also included vaccines for meningococcus type B, and more new orphan drugs for rare diseases than any previous year in our history.
Accomplishments: Devices
We’ve also made strides with medical devices. As a result of activities coordinated by CDRH Innovation, and programmatic improvements and innovative use of our existing approval and clearance pathways, many devices investigated in the United States now reach the market a full year sooner than they did at the beginning of this decade.
Products recently approved or cleared by FDA include the BrainPort V100, a first-of-its-kind wearable device that can help orient profoundly blind individuals to their physical surroundings; Watchman LAA Closure Technology, a permanently implanted device that prevents certain clots from entering the bloodstream and potentially causing a stroke; and the Maestro Rechargeable System to treat obesity in certain adult patients (it targets the nerve pathway between the brain and the stomach that controls feelings of hunger and fullness).
Learn More
Here, on these pages, you’ll find timely materials on what we’re doing to encourage innovation that helps patients.
You’ll see related links to news releases, blogs, fact sheets, reports, speeches and testimony. You’ll also see links to our webpages that highlight scientific activities at our various medical centers.
Please be sure to bookmark this page because we’ll be updating it on a regular basis.
What's New
- FDA approves Cinqair to treat severe asthma
- Changing course: A new approach to opioid pain medication at FDA
- FDA permits marketing of device that senses optimal time to check patientâs eye pressure
- FDA providing $2 million in new grants for natural history studies in rare diseases
- 2016: The year of diversity in clinical trials