Early phase clinical trial played a critical role in the Food and Drug Administration–approved indications for targeted anticancer drugs: a cross-sectional study from 2012 to 2021 - ScienceDirect
FDA 101: A Primer on IDEs - Clinical and Translational Science Institute - University at Buffalo
Early feasibility studies in the United States: Focus on electrophysiology - Weiss - 2023 - Journal of Cardiovascular Electrophysiology - Wiley Online Library
Characteristics of Single Pivotal Trials Supporting Regulatory Approvals of Novel Non‐orphan, Non‐oncology Drugs in the European Union and United States from 2012−2016 - Morant - 2019 - Clinical and Translational Science - Wiley Online Library
The use of external controls in FDA regulatory decision making - UC Berkeley Public Health
The 3 Stages For Medical Device Clinical Investigation Explained
![Design of the pivotal Study 311 [19] and Study 312 [13, 20] phase 3... | Download Scientific Diagram](https://www.researchgate.net/publication/350164644/figure/fig1/AS:1021236666703872@1620493203303/Design-of-the-pivotal-Study-311-19-and-Study-312-13-20-phase-3-clinical-trials.png "Design of the pivotal Study 311 [19] and Study 312 [13, 20] phase 3... | Download Scientific Diagram")
Design of the pivotal Study 311 [19] and Study 312 [13, 20] phase 3... | Download Scientific Diagram
The Winding Journey From EFS/FIH to Pivotal Study: How to Work Closely With the FDA Through the Ups and Downs | tctmd.com
Sample construction of novel therapeutic agents approved by the U.S.... | Download Scientific Diagram
Approval Process
Early Feasibility Studies for Cardiovascular Devices in the United States: JACC State-of-the-Art Review - ScienceDirect
Medical Device Clinical Trials: Regulatory Pathways & Study Types Explained
FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Non-Comparative Clinical Outcome Studies | RegDesk
Joachim Eeckhout on LinkedIn: #crispr #biotech
Summary of pivotal study designs for evaluating the efficacy of human... | Download Table
Nearly 20% of therapeutic devices cleared without pivotal clinical study
Clinical Trial Phases Explained: The Ultimate Guide | Power
Metavention's Renal Denervation Pivotal IDE Study now Approved by FDA for the Treatment of Hypertension
With results of pivotal study, AppliedVR to seek FDA clearance - MedCity News
Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA | Trials | Full Text
Clinical Trial Phases | Power
Sample construction for pivotal trials using surrogate markers with... | Download Scientific Diagram
Attachment E CDRH Final Guidance Cover Sheet
