In:
International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 3, No. 1 ( 2018-02-13), p. 41-61
Abstract:
A regulatory process, by which a person/organization/sponsor/innovator gets authorization to launch a drug in the market, is known as drug approval process. The United States - Food and Drug Administration (U.S. FDA) has its own regulatory strategy to approve and allow generic drugs in to the market, which is named as Generic Drug Submission Review. FDA would like to slash the review time of generic drug application without compromising the quality and efficacy of proposed generic drugs for the intended use and to make them available to consumers in short time as possible. FDA has introduced Generic Drug User Fee program to supplement appropriate funding for resource management to ensure that consumers continue to receive the significant benefits offered by generic drugs. The purpose of this article is to present a concise overview about Generic Drug User Fee program and the recent advances in Abbreviated New Drug Application (ANDA) review process.
Type of Medium:
Online Resource
ISSN:
2321-6794
,
2321-7162
DOI:
10.22270/ijdra.v3i1.157
Language:
Unknown
Publisher:
Society of Pharmaceutical Tecnocrats
Publication Date:
2018
detail.hit.zdb_id:
2738279-5
SSG:
15,3
