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FDA

Person
Mentions
0
Relationships
5
Events
21
Documents
0
Also known as:
FDA Staff
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Event Timeline

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5 total relationships
Connected Entity Relationship Type
Strength (mentions)
Documents Actions
person Cannabis Investment Report
Unknown
6
1
View
person DHHS
Agency hierarchy
5
1
View
person Scott Gottlieb
Unknown
5
1
View
person Robert Temple
Employment
5
1
View
person Janet Woodcock, MD
Employment
5
1
View
Date Event Type Description Location Actions
N/A N/A FDA convened meeting to analyze drug data. N/A View
N/A N/A The FDA clearing the drug Praluent for patients with heterozygous familial hypercholesterolemia a... N/A View
N/A N/A FDA convened a meeting to analyze data on the drug Praluent, leading to its approval for a larger... U.S. View
N/A N/A FDA public meeting to gather stakeholder input on CBD products. Unknown View
2018-01-01 N/A Changes in Swiss law regarding pharmaceutical grade pure CBD following US FDA approval of Epidiolex. Switzerland View
2018-01-01 N/A Expected FDA approval of a cannabis-derived pharmaceutical USA View
2018-01-01 N/A FDA approval of GW's Epidiolex USA View
2018-01-01 N/A NDA submission leading to FDA approval USA View
2017-10-01 N/A Submission of a New Drug Application (NDA) for a cannabis-derived pharmaceutical. United States View
2017-10-01 N/A FDA accepted GW Pharmaceuticals’ New Drug Application (NDA) for the cannabis-derived drug Epidiolex. USA View
2017-08-01 N/A FDA updated guidance regarding THC/CBD in foods. United States View
2016-12-01 N/A FDA published industry guidance on botanical drug development. USA View
2016-12-01 N/A FDA published 'Botanical Drug Development; Guidance for Industry'. United States View
2016-01-01 N/A Syndros approved by the FDA USA View
2013-11-14 N/A Publication of 'Expediting Drug Development – The FDA’s New Breakthrough Therapy Designation' in ... N/A View
2012-01-01 N/A Creation of the breakthrough therapy designation under FDASIA. USA View
2009-01-01 N/A FDA gave green light for Geron clinical trial. US View
2004-06-01 N/A Previous FDA guidance on botanical drugs issued. USA View
1993-01-01 N/A FDA approval of FC1 Female Condom USA View
1992-01-01 N/A Marinol approved for treatment of anorexia associated with AIDS USA View
1985-01-01 N/A FDA approval of Marinol and Cesamet USA View
No documents found for this entity.
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Total Paid
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0 total transactions
No financial transactions found for this entity. Entity linking may need to be improved.
As Sender
2
As Recipient
5
Total
7

Reporting Negative Side Effects

From: Not specified
To: FDA

1-800-FDA-1088

Phone
N/A
Communication Source

Reporting negative side effects

From: Not specified
To: FDA

Provides a phone number (1-800-FDA-1088) and website (www.fda.gov/medwatch) for reporting drug side effects to the FDA.

Public information line
N/A
Communication Source

MedWatch Program

From: Not specified
To: FDA

www.fda.gov/medwatch

Website
N/A
Communication Source

FDA Reporting

From: Not specified
To: FDA

Phone number for reporting negative side effects to the FDA: 1-800-FDA-1088.

Phone number
N/A
Communication Source

Update federal regulations governing hemp-derived ingredi...

From: Ron Wyden
To: FDA

Urging the agency to update federal regulations governing the use and interstate sale of certain hemp-derived ingredients.

Letter
2019-01-15
Communication Source

Cannabis/THC/CBD in foods

From: FDA
To: Public/Industry

Concluding FD&C Act does not permit foods with added THC/CBD in interstate commerce.

Guidance publication
2017-08-01
Communication Source

Botanical Drug Development; Guidance for Industry

From: FDA
To: Celebrities in the mov...

Discusses regulatory policies for botanical drugs.

Guidance document
2016-12-01
Communication Source

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