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- Title
The Value of Pre--FDA Approval Healthcare Economic Information Exchange Between Payers and Drug Manufacturers.
- Authors
Fendt, Peter R.; Ung, Brian; Vogenberg, F. Randy
- Abstract
The article informs that ledipasvir plus sofosbuvir is providing renewed hope for patients with certain chronic hepatitis C virus (HCV) genotypes in October 2014. Topics discussed include Section 114 of the Food and Drug Administration Modernization Act of 1997 (FDAMA), Section 3037 of the Cures Act in a recent draft guidance the FDA and new treatment options for patients for breakthrough therapies.
- Subjects
UNITED States; DRUGS &; economics; DRUG laws; HEALTH insurance &; economics; DRUG labeling; PHARMACEUTICAL industry; UNITED States. Food &; Drug Administration; DRUG approval; ACCESS to information
- Publication
American Health & Drug Benefits, 2017, Vol 10, Issue 8, p424
- ISSN
1942-2962
- Publication type
Article