Sample construction for pivotal trials using surrogate markers with... | Download Scientific Diagram
FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Non-Comparative Clinical Outcome Studies | RegDesk
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
Attachment E CDRH Final Guidance Cover Sheet
Summary of pivotal study designs for evaluating the efficacy of human... | Download Table
Early feasibility studies in the United States: Focus on electrophysiology - Weiss - 2023 - Journal of Cardiovascular Electrophysiology - Wiley Online Library
Study: 10% of FDA approved drugs since 2018 had pivotal trials that missed primary endpoints | RAPS
Mainz Biomed Announce IRB Approval and Initiation of US Pivotal FDA Clinical Study | Technology Networks
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
Early Feasibility Studies for Cardiovascular Devices in the United States: JACC State-of-the-Art Review - ScienceDirect
FDA 101: A Primer on IDEs - Clinical and Translational Science Institute - University at Buffalo
Real-Time Oncology Review | FDA
Characteristics of Pivotal Trials and FDA Review of Innovative Devices | PLOS ONE
Research Milestones — Tufts CSDD
With results of pivotal study, AppliedVR to seek FDA clearance - MedCity News
FDA Approves RECOVER IV Randomized Controlled Trial with Exception from Informed Consent (EFIC) | DAIC
Major pivotal study leads to FDA approval of the Vivistim Paired VNS System for treatment of upper limb impairments after chronic ischemic stroke | VJNeurology
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
Sample construction of novel therapeutic agents approved by the U.S.... | 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
Jim Yearick on LinkedIn: Endotronix Announces FDA Approval for PROACTIVE-HF Pivotal Trial Design…
PQ Bypass Announces Unconditional IDE Approval from U.S. FDA for Pivotal Study. - Seroba Life Sciences
