GENERIC DRUGS
FDA Should Make Public Its Plans to Issue and Revise Guidance on Nonbiological Complex Drugs
Business & Finance, Accounting, Governmental
| Author: | Hugues Dumont | ISBN: | 1230002138183 |
| Publisher: | Hugues DUMONT | Publication: | February 3, 2018 |
| Imprint: | Language: | English |
| Author: | Hugues Dumont |
| ISBN: | 1230002138183 |
| Publisher: | Hugues DUMONT |
| Publication: | February 3, 2018 |
| Imprint: | |
| Language: | English |
Generic versions of brand-name drugs provide substantial cost savings for patients and the U.S. health care system. FDA, an agency within the Department of Health and Human Services (HHS), has approved generic versions of NBCDs. Some industry stakeholders have asserted that, because it is difficult to assess equivalence for these complex drugs, there could be safety and efficacy problems that might not appear until after generic versions are on the market...
Generic versions of brand-name drugs provide substantial cost savings for patients and the U.S. health care system. FDA, an agency within the Department of Health and Human Services (HHS), has approved generic versions of NBCDs. Some industry stakeholders have asserted that, because it is difficult to assess equivalence for these complex drugs, there could be safety and efficacy problems that might not appear until after generic versions are on the market...
