Fast Track Drugs Come to Market in the U.S. with FDA Cooperation
Just published—our 2021 edition. Order now!
Despite exponential advances in biopharmaceutical knowledge and technology, biotech companies enduring the task of getting new drugs to market continue to face long timeframes, daunting costs and immense risks. Meanwhile, the patent expiration clock is ticking—soon enough, manufacturers of generic alternatives steal market share from the firms that invested all that time and money in the development of the original drug.
The FDA is attempting to help the drug industry bring the most vital drugs to market in shorter time with programs that include: Fast Track, Priority Review, Breakthrough Therapy Designation and Accelerated Approval. The benefits of Fast Track include scheduled meetings to seek FDA input into development as well as the option of submitting a New Drug Application in sections rather than submitting all components at once. The Fast Track designation is intended for drugs that address an unmet medical need. Breakthrough therapies show early clinical evidence of very important improvements over currently available drugs. Generally, Fast Track approval is reserved for diseases that are life-threatening and have no current therapies, such as rare forms of cancer. However, new policies are setting the stage for accelerated approval of drugs for less deadly but more pervasive conditions such as diabetes and obesity.
For everything you need to know about Biotech, Pharmaceuticals & Genetics companies, see:
Plunkett’s Biotech, Pharmaceuticals & Genetics Almanac 2021
Available to Plunkett Research Online subscribers
See more information about the online edition here.
Also available in Almanac Editions.
Publication Date: August 2020 Price: $379.99
Printed ISBN: 978-1-62831-580-6
eBook ISBN: 978-1-62831-887-6
See the complete listings of book contents and details here.