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Here is another article on the creation of

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Anavex Life Sciences Provides Update on Clinical Program Development as Response to COVID-19 GlobeNewswire Inc. - 3/31/2020 7:00:10 AM
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Anavex Life Sciences Announces Fast Track Designation Granted by U.S. FDA for ANAVEX®2-73 (blarcamesine) Clinical Developmen... GlobeNewswire Inc. - 2/3/2020 7:00:10 AM
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Anavex Life Sciences Issued New U.S. Patent for ANAVEX®2-73 Treatment of Neurodevelopmental Disorders including Rett Syndrom... GlobeNewswire Inc. - 1/8/2020 7:00:10 AM
Anavex Life Sciences Reports Fiscal Year 2019 Financial Results And Provides Clinical Study Updates GlobeNewswire Inc. - 12/16/2019 7:00:10 AM
Anavex Life Sciences to Announce Fiscal 2019 Year End Financial Results on Monday December 16, 2019 GlobeNewswire Inc. - 12/10/2019 7:00:10 AM
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Anavex Life Sciences Presents ANAVEX®2-73 (blarcamesine) Data at 12th Clinical Trials on Alzheimer's Disease (CTAD) 2019 Con... GlobeNewswire Inc. - 12/4/2019 7:00:10 AM
Anavex Life Sciences Receives Rare Pediatric Disease Designation from FDA for ANAVEX®2-73 (blarcamesine) for the Treatment o... GlobeNewswire Inc. - 11/14/2019 7:00:00 AM
Anavex Life Sciences Announces Publication of Foundational Data for ANAVEX®2-73 (blarcamesine) in Rett Syndrome GlobeNewswire Inc. - 11/6/2019 7:00:00 AM
Anavex Life Sciences Announces ATTENTION-AD ANAVEX®2-73 Extension Clinical Study in Early Alzheimer’s Disease GlobeNewswire Inc. - 10/9/2019 7:00:00 AM
Anavex Life Sciences Issued New U.S. Patent for Composition of Matter Covering ANAVEX®2-73 for the Treatment of Alzheimer’... GlobeNewswire Inc. - 10/2/2019 7:00:00 AM
Anavex Life Sciences Presented at the 6th Annual European Rett Syndrome Conference Preliminary Clinical Efficacy Data from th... GlobeNewswire Inc. - 9/27/2019 3:00:00 AM
mapman1010   Tuesday, 01/08/19 06:32:31 PM
Re: Biostockclub post# 177936
Post # of 244750 
Here is another article on the creation of the office of innovation:

https://www.fiercebiotech.com/biotech/fda-creating-innovation-office-to-make-drug-development-faster

Quote:


In practice, that belief will manifest in 51-person Office of Drug Evaluation Science made up of groups focused on clinical outcome assessments, biomedical informatics and safety analytics and biomarker development.
Around one-fifth of the office’s workforce will focus on creating more structured approaches to the evaluation of biomarkers, which Gottlieb thinks are ready to play a “much more formal” role in drug development and review. One strand of the biomarker unit’s activities will seek to develop standards in collaboration with drug developers, academics and other stakeholders.
Another third of the office’s 51 employees will work on biomedical informatics and safety analytics. Gottlieb said these staff will build “a standardized tool for capturing and formatting safety data” to make the agency’s reviews of safety data more structured and consistent.
If the initiative advances as hoped, it will serve as a stepping stone to a new way of managing drug application reviews. The new approach foreseen by Gottlieb will build on advances in data handling and cloud computing to give the FDA a more active role in how the information underpinning filings is presented and evaluated.
“Applications will be cloud based and instead of taking the sponsors' charts and tables and evaluating their charts and tables, we’ll be pulling down their bottom line data and formatting it through our own assessment tools and creating our own charts and tables to do the evaluation,” Gottlieb said.
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This is what I expected Gottlieb was working on over a year ago but had to step back a bit to get a feel for how the new HHS Secretary Azar would react to his vision of new regulatory innovations.

I believe Missling is/was aware/involved in these discussions and had to step back a lttle as well. JMHO



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