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. Read More
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