Common bioanalytical deficiencies with bioequivalence submissions in Abbreviated New Drug Applications

Bioanalysis ◽  
2014 ◽  
Vol 6 (4) ◽  
pp. 441-445 ◽  
Author(s):  
Leah N Williamson ◽  
Dale P Conner ◽  
Ethan M Stier ◽  
Barbara M Davit
Keyword(s):  
New Drug ◽  
Abbreviated New Drug Applications

Common Filing Deficiencies in Abbreviated New Drug Applications Containing Clinical Endpoint Studies

2019 ◽  
Vol 53 (1) ◽  
pp. 81-85
Author(s):  
Lewis J. Fermaglich ◽  
Ru Chen ◽  
Carol Y. Kim ◽  
Eunjung Esther Chuh ◽  
Teena Thomas ◽  
...  
Keyword(s):  
Clinical Endpoint ◽  
New Drug ◽  
Abbreviated New Drug Applications

The Drug Approval Process and the Information it Provides

1987 ◽  
Vol 21 (10) ◽  
pp. 821-826 ◽  
Author(s):  
Ann Myers ◽  
Steven R. Moore ◽  
Abraham G. Hartzema ◽  
Miquel S. Porta ◽  
Hugh H. Tilson
Keyword(s):  
Drug Administration ◽  
Drug Approval ◽  
Specific Information ◽  
Approval Process ◽  
The Public ◽  
New Drug ◽  
Drug Approval Process ◽  
Organizational Procedures ◽  
Abbreviated New Drug Applications ◽  
The U.S

By law, the commissioner of the Food and Drug Administration (FDA) is responsible for determining whether a new drug is safe and efficacious before it is approved for marketing in the U.S. and for monitoring its use after approval. This paper provides a brief overview of the approval process, in terms of responsibilities of the sponsor in submitting an application for review to the FDA and FDA's responsibilities and organizational procedures for reviewing and approving those applications. A brief history on the legislation regarding the FDA's responsibility in the drug approval area is discussed along with recent regulations, legislation, and FDA initiatives aimed at improving the drug approval process. Specific information that can be released to the public upon request is also discussed. This paper is limited to the regulation of drugs; somewhat different regulations govern the review and regulation of biological products and abbreviated new drug applications.

Pharmaceutical impurities: Regulatory perspective for Abbreviated New Drug Applications☆☆☆

2007 ◽  
Vol 59 (1) ◽  
pp. 64-72 ◽  
Author(s):  
A BASAK ◽  
A RAW ◽  
A ALHAKIM ◽  
S FURNESS ◽  
N SAMAAN ◽  
...  
Keyword(s):  
New Drug ◽  
Regulatory Perspective ◽  
Pharmaceutical Impurities ◽  
Abbreviated New Drug Applications

Common Deficiencies of in vitro Binding Bioequivalence (BE) Studies Submitted in Abbreviated New Drug Applications (ANDAs)

2018 ◽  
Vol 20 (2) ◽  
Author(s):  
Dongmei Lu ◽  
Diana Vivian ◽  
Ping Ren ◽  
Yongsheng Yang ◽  
Hongling Zhang ◽  
...  
Keyword(s):  
In Vitro Binding ◽  
New Drug ◽  
Vitro Binding ◽  
Abbreviated New Drug Applications
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