We have located links that may give you full text access.
Drugs, Devices, and the FDA: Part 1: An Overview of Approval Processes for Drugs.
JACC. Basic to Translational Science 2016 April
Over the last 150 years, the U.S. Food and Drug Administration (FDA) has evolved from a small division of the U.S. Patent Office to 1 of the largest consumer protection agencies in the world. Its mission includes ensuring that new medical treatments reach the public as quickly as possible while simultaneously ensuring that new treatments are both safe and effective. In the face of urgent consumer need, the FDA has faced criticism that its processes are too lengthy and costly and that the time to new drug release is significantly longer in the United States than in other Western countries. Calls from the public to loosen FDA regulations to facilitate more rapid approval of drugs and devices have been countered by the occurrence of patient harm and deaths after some approved drugs have reached the marketplace. New drug and device approval in the United States take an average of 12 and 7 years, respectively, from pre-clinical testing to approval. Costs for development of medical devices run into millions of dollars, and a recent study suggests that the entire cost for a new drug is in excess of $1 billion. For investigators seeking approval for new drugs and devices, FDA processes can be formidable. This 2-part series is intended to provide an overview of the steps involved in bringing new drugs and devices through the FDA process. Part 1 concerns the process of new drug approvals. Part 2 continues with approval of medical devices.
Full text links
Related Resources
Trending Papers
Consensus Statement on Vitamin D Status Assessment and Supplementation: Whys, Whens, and Hows.Endocrine Reviews 2024 April 28
The Tricuspid Valve: A Review of Pathology, Imaging, and Current Treatment Options: A Scientific Statement From the American Heart Association.Circulation 2024 April 26
Intravenous infusion of dexmedetomidine during the surgery to prevent postoperative delirium and postoperative cognitive dysfunction undergoing non-cardiac surgery: a meta-analysis of randomized controlled trials.European Journal of Medical Research 2024 April 19
Interstitial Lung Disease: A Review.JAMA 2024 April 23
Management of Diverticulitis: A Review.JAMA Surgery 2024 April 18
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app
All material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
This website also contains material copyrighted by 3rd parties.
By using this service, you agree to our terms of use and privacy policy.
Your Privacy Choices
You can now claim free CME credits for this literature searchClaim now
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app