March 20, 2017Regulatory
The FDA 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, FDA has 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.
As a result of these efforts, in 2014 alone, FDA approved 51 new molecular entities and biological products (41 by the Center for Drug Evaluation and Research and 10 by the 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.
FDA has 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).