We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Approximating Future Generic Entry for New Drugs.
- Authors
Beall, Reed F.; Darrow, Jonathan J.; Kesselheim, Aaron S.; Cook-Deegan, Robert; Majumder, Mary A.; McGuire, Amy L.
- Abstract
The article discusses research regarding the approximation of future generic entry of new drugs in America as of 2019, and it mentions drug patents, drug approval by the U.S. Food and Drug Administration (FDA), and innovative drugs with new chemical entities (NCEs). America's Orphan Drug Act, the expiration dates for manufacturers' drug patents, and special exclusivity extensions for drug makers are assessed, along with the U.S. 1984 Hatch-Waxman Act.
- Subjects
UNITED States; GENERIC drugs; DRUG approval; DRUG patents; EXPIRATION; ORPHAN drug laws; DRUG factories; UNITED States. Food &; Drug Administration; ORPHAN drugs; DRUGS; MARKETING; MEDICAL care costs; PATIENT compliance; QUALITY assurance; RARE diseases; ECONOMICS; THERAPEUTICS
- Publication
Journal of Law, Medicine & Ethics, 2019, Vol 47, Issue 1, p177
- ISSN
1073-1105
- Publication type
Article
- DOI
10.1177/1073110519840499