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Regulatory Application Sponsor

Known as: Application Sponsor, RegulatoryApplicationSponsor, Drug Sponsor 
The party who submits a marketing application to FDA for approval of a drug, device, or biologic product. An applicant is the person or entity who… 
National Institutes of Health

Papers overview

Semantic Scholar uses AI to extract papers important to this topic.
2014
2014
DrugPath: a database for academic investigators to match oncology molecular targets with drugs in development
AbstractPurpose Academic laboratories are developing increasingly large amounts of data that describe the genomic landscape and… 
2014
2014
The Pharmaceutical Year That Was, 2014
Review
2013
Review
2013
An invitation for comprehensive single-compound reviews on the pharmacological properties of newly launched drugs
2012
2012
Beyond genetic tests and biomarkers: what about therapeutic misconception?
Clinical trials are a vital part of the drug development process because they test the safety and efficacy of potential… 
2012
2012
Closing the information gap: informing better medical decisionmaking through the use of post-market safety and comparative effectiveness information.
While FDA gathers vast amounts of data about prescription drugs prior to their marketing approval, important information about… 
2006
2006
Investigational Drugs and the Constitution
In May 2006, a federal court of appeals issued a decision with radical implications for U.S. drug regulation. The ruling in… 
Review
2004
Review
2004
Expanded access program (EAP) to investigational drugs.
6001 Background: Title 21 part 312.34 of the Code of Federal Regulations provides for use of unapproved drugs to treat patients… 
2002
2002
The IPEC-Americas: Excipient master file guide
The International Pharmaceutical Excipients Council (IPEC) is developing a global master file guide to meet the need to submit… 
1998
1998
The Ich Guideline for Stability Testing—What Matrixing Does It Permit?
This paper examines the allowance for matrix designs in stability testing included in the 1993 International Conference on… 
1993
1993
Discussion: Frank W Rockhold and G Enas, data monitoring and interim analyses in the pharmaceutical industry: Ethical and logistical considerations: George W Williams et al, monitoring of clinical…
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