Event Details

January 01, 2012

Description

Creation of the breakthrough therapy designation under FDASIA.

Participants (1)

Name Type Mentions
FDA person 0 View Entity

Source Documents (1)

HOUSE_OVERSIGHT_024018.jpg

Investment Prospectus / Fund Strategy Document • 2.62 MB
View

This document appears to be a page from a confidential investment prospectus for a fund named 'NLV-III' (likely New Leaf Ventures). It outlines the investment strategy, focusing on biopharmaceutical trends such as FDA 'breakthrough therapy' designations and 'information convergence' in healthcare to reduce costs. The document cites a 2013 editorial by FDA Director Janet Woodcock and notes the evolving commercial models of large pharmaceutical companies.

Related Events

Events with shared participants

FDA convened a meeting to analyze data on the drug Praluent, leading to its approval for a larger group of patients than expected.

Date unknown • U.S.

View

The FDA clearing the drug Praluent for patients with heterozygous familial hypercholesterolemia and certain types of heart disease.

Date unknown

View

FDA approval of Marinol and Cesamet

1985-01-01 • USA

View

Marinol approved for treatment of anorexia associated with AIDS

1992-01-01 • USA

View

Syndros approved by the FDA

2016-01-01 • USA

View

FDA gave green light for Geron clinical trial.

2009-01-01 • US

View

FDA accepted GW Pharmaceuticals’ New Drug Application (NDA) for the cannabis-derived drug Epidiolex.

2017-10-01 • USA

View

FDA published industry guidance on botanical drug development.

2016-12-01 • USA

View

Previous FDA guidance on botanical drugs issued.

2004-06-01 • USA

View

FDA convened meeting to analyze drug data.

Date unknown

View

Event Metadata

Type
Unknown
Location
USA
Significance Score
5/10
Participants
1
Source Documents
1
Extracted
2025-11-20 22:33

Additional Data

Source
HOUSE_OVERSIGHT_024018.jpg
Date String
2012

Discussion 0

Sign in to join the discussion

No comments yet

Be the first to share your thoughts on this epstein event