Tuesday, April 23, 2019 1:00:54 PM
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Coming change in FDA process - the office of innovation (Office of Drug Evaluation Science) 1/8/19:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145956816
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145966349
3/14/19 Update from Gottlieb on changes in drug trial procedure
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147558978
New(Feb 2019) guidance highlights basis for possible early approval of 2-73:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=146543702
Reasons why it's good to be running trials in Australia...
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=140883830
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147033379
How RWE data will be used and new systems will be applied. (from nidan7500)
https://www.fda.gov/downloads/ScienceResearch/SpecialTopics/RealWorldEvidence/UCM627769.pdf
Precedents and legal pathways to approval from Biostockclub & Nidan:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145205166
New FDA accelerated approval guidance for labeling - from Nidan7500
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM390058.pdf
FDA planning new guidance, hires in cell and gene therapies for 2019 (From basparks79)
https://www.fiercebiotech.com/biotech/fda-planning-new-guidance-hires-cell-and-gene-therapies-for-2019
Link from the above post naming precedents for drug approval without a Random Controlled Trial:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4932294/#!po=95.1923
New Rare Disease Draft Guidance (Feb. 2019 from nidan7500)
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM629579.pdf?rel=0
Electronic Health Records to be used in FDA trials (from Rubyred77)
https://ehrintelligence.com/news/ehr-data-to-provide-real-world-evidence-for-clinical-trials
New guidance for early stage Alzheimer's being developed in the U.S.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145205259
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145208035
What is a Special Protocol Assessment?
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=140087471
Check this out on retrospective validation: (from Nidan7500)
https://www.nature.com/articles/6500363#hypothetical-safety-example-seeking-drug-approval-in-the-dnasubgroup-of-patients-with-less-risk-of-a-cardiovascular-adverse-events-after-trial-completion
4/3/19 - New position paper from FDA on AI supports Cognision partnership
(see Anavex Partners link at bottom of post for more on Cognision)
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147990271
A 1995 paper predicts loss of U.S. credibility in drug approval:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145668454
Alzheimer's research receives largest ever funding boost in 2019 budget
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=143880556
Are blinded, placebo trials really necessary?
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147253537
Is corporate dominance of the FDA achieved by the User Fee Act (PDUFA)?
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147227616
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147231843
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147234966
New programs to promote drug manufacturing innovation anounced by Gottleib(from Kevli33)
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631293.htm?utm_campaign=021319_Statement_FDA%20announces%20programs%20to%20promote%20adoption%20of%20innovations%20in%20drug%20manufacturing&utm_medium=email&utm_source=Eloqua
Woodcock says the clinical trial system is broken. (From nidan7500)
https://www.biopharmadive.com/news/fdas-woodcock-the-clinical-trial-system-is-broken/542698/
Did the FDA cause the opioid crisis (from tradeherpete)
https://www.cbsnews.com/news/opioid-epidemic-did-the-fda-ignite-the-crisis-60-minutes/?ftag=MSF0951a18
On ACTC participation in the U.S.:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144487503
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145208260
Why ACTC is the holdup in North American Alzheimer's trials:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145449081
Update on NIH/ACTC (from Talon38)
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147089795
Anavex, ACTC and Paul Aisen:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147089981
The pace of NIH-ACTC movement is Glacial. (from Nidan7500)
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147091783
Alzheimer’s Disease conference, held October 24–27 2018 in Barcelona, Spain,
Which Are the Right Tests to Satisfy New FDA Guidance?
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145129244
CDER expediting drugs - post from 04/08/19
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148080157
Payers and Right to Try:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148132893
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