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Legal Reform Proposals Arising from the Food and Drug Administration Generic Drug Scandal

Year: 1992

Type: article

Abstract: This study was undertaken with the help of generic drug manufacturers to learn their perceived reasons for delay in Abbreviated New Drug Application (ANDA) by the Food and Drug Administration (FDA). The research resulted into proposing legal reforms in existing laws to prevent ANDA scandals in the future.

Source: Clinical Research and Regulatory Affairs

DOI: 10.3109/10601339209005326

Authors: Rupendra Simlot, Norman A. Campbell

Institution: University of Rhode Island

Language: English

Topic: Pharmaceutical Economics and Policy

Subfield: Economics and Econometrics

Field: Economics, Econometrics and Finance

Domain: Social Sciences

SDG: Peace, justice, and strong institutions

Open Access status: green

OpenAlex ID: W2116973591

FWCI:

Cites: 3

Cited by:

Related to: 10