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1.95 MB
Extraction Summary
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People
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Organizations
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Locations
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Events
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Relationships
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Quotes
Document Information
Type:
Investment report / regulatory analysis
File Size:
1.95 MB
Summary
This document is page 74 of a 'Cannabis Investment Report' published by Ackrell Capital in December 2017. It details the regulatory framework for drugs under the FD&C Act, defining what constitutes a drug and outlining the FDA's four-step approval process (from animal testing to New Drug Application). The document bears a 'HOUSE_OVERSIGHT_024710' Bates stamp, indicating it was part of a document production for a Congressional investigation.
Organizations (5)
| Name | Type | Context |
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| Ackrell Capital, LLC |
Header and footer branding
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| FDA |
Mentioned extensively regarding drug regulation and approval processes
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| FINRA |
Member organization listed in footer
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| SIPC |
Member organization listed in footer
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| House Oversight Committee |
Implied by Bates stamp 'HOUSE_OVERSIGHT'
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Locations (1)
| Location | Context |
|---|---|
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Implied by 'interstate commerce', 'U.S. Pharmacopoeia', and FDA jurisdiction
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Key Quotes (3)
"Generally, the FD&C Act defines a 'drug' as any one of the following..."Source
HOUSE_OVERSIGHT_024710.jpg
Quote #1
"The FD&C Act generally prohibits a company from introducing a drug into interstate commerce without the FDA having first approved the drug as safe and effective for treating a specified medical condition."Source
HOUSE_OVERSIGHT_024710.jpg
Quote #2
"FDA approval of a drug as safe and effective for treating a specified medical condition generally involves the following steps..."Source
HOUSE_OVERSIGHT_024710.jpg
Quote #3
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