Duration: (37) ?Subscribe5835 2025-02-08T06:52:44+00:00
FDA Study Data Technical Conformance Guide version 4.2 – Nov. 27, 2018
(46:23)
Some cancer drugs remain unproven 5 years after FDA's accelerated approval, study finds
(7:44)
FDA’s Clinical Regulatory Perspective: Designing First-In-Human Trial for Cellular and Gene Therapy
(36:56)
Lecture 3 - FDA Drug Approval 101- Reading and Interpreting Cancer Trials Series
(47:8)
FDA Study Data Technical Rejection Criteria (TRC): What you need to know!
(1:26:22)
Harvard-MIT Center for Reg. Science Lecture (4-4-23) - Dubious FDA drug Approvals
(57:39)
FDA Study Data Technical Conformance Guide v4.4 - Nov 22, 2019
(1:9:42)
What you should know about FDA Project Optimus for your oncology drug approval
(42:27)
FDA Clinical Investigator Training Course (CITC) 2024 – Day One – Session One
(2:14:51)
Demystifying FDA's Human Factors Guidance
(1:10:44)
The Food and Drug Administration Explained
(17:31)
New study of human brains shows there are enough microplastics to make a spoon
(5:22)
Should You Supplement With Berberine? - Rhonda Patrick
(15:36)
Basic SDTM concepts 1
(24:4)
Innovating medicine with AI: Here's what to know
(6:49)
WATCH: Sen. Bernie Sanders questions RFK Jr. in confirmation hearing
(8:21)
Assessment of Extractables/Leachables Data in ANDA Submissions
(31:55)
Chemistry and Manufacturing Requirements for Early Clinical Development: What’s in there? Prove it.
(1:2:19)
STUDY W/ ME (my entire study process + tips) 💻☆
(13:23)
Safety Reporting Requirements and Safety Assessment for IND and BA/BE Studies
(35:38)
FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence
(2:1:2)
An In-Depth Look at the Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs
(2:35:24)
Recent FDA Feedback Regarding Extractable and Leachable Testing
(47:26)
10 More Facts about What FDA Does and Does Not Approve | #FDAFacts 11-20
(5:27)
Introduction (1/9) FDA MyStudies Mobile App System – May 9, 2019
(15:38)
FDA Clinical Investigator Training Course (CITC) 2024 (Day 1 of 3)
(4:38:30)
June 17, 2021- Introduction to FDA: History, Regulations, and Clinical Trial Design
(54:27)
How FDA Investigates Foodborne Illness Outbreaks
(12:8)
Webinar — Comparing CTA Submission (EMA/Health Canada) to IND Applications (FDA) for Phase I Trials
(51:57)
Walkthrough of an FDA Clinical Investigator Site Inspection (12/14) REdI 2017
(39:9)