The FDA's generic-drug approval process: similarities to and differences from brand-name drugs.

Title

The FDA's generic-drug approval process: similarities to and differences from brand-name drugs.

Creator

Kefalas Costas H; Ciociola Arthur A

Publisher

The American journal of gastroenterology

Date

2011
2011-06

Subject

Clinical Trials; Drug Approval/*methods; Drug Labeling/standards; Drugs; Female; Generic/administration & dosage/*pharmacology; Humans; Male; Pharmaceutical Preparations/administration & dosage; Phase I as Topic; Phase II as Topic; Phase III as Topic; Sensitivity and Specificity; Therapeutic Equivalency; United States; United States Food and Drug Administration/*standards

Identifier

10.1038/ajg.2011.29

Rights

Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).

URL Address

http://doi.org/10.1038/ajg.2011.29

Pages

1018–1021

Issue

6

Volume

106

Citation

Kefalas Costas H; Ciociola Arthur A, “The FDA's generic-drug approval process: similarities to and differences from brand-name drugs.,” NEOMED Bibliography Database, accessed January 19, 2025, https://neomed.omeka.net/items/show/3980.