FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Integrating Trials into Clinical Practice Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Integrating Randomized Controlled Trials for Drug and Biolo...

Positive Data Reported on Lung Cancer Therapy

[ Price : $8.95]

Merck and Daiichi Sankyo say their HERTHENA-Lung02 Phase 3 trial evaluating patritumab deruxtecan in certain patients with locally...

Advisory Panel to Weigh AI-Enabled Devices

[ Price : $8.95]

Federal Register notice: FDA announces an 11/20-21 Digital Health Advisory Committee meeting to discuss generative artificial inte...

Oncology Drug Multiregional Clinical Trial Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Considerations for Generating Clinical Evidence From Oncolo...

Transplant Viral Nucleic Acid Tests in Class 2

[ Price : $8.95]

Federal Register notice: FDA classifies quantitative viral nucleic acid tests for transplant patient management into Class 2 (spec...

Integrating RCTs into Routine Clinical Practice

[ Price : $8.95]

FDA publishes a guidance on integrating clinical trials into routine clinical practice.

Safety Alert on Zimmer Hip System

[ Price : $8.95]

FDA issues a safety alert about an increased risk of thigh bone fracture after surgery with the use of the Zimmer Biomet CPT Hip S...

Decentralized Clinical Trial Guidance

[ Price : $8.95]

FDA publishes a guidance on the conduct of clinical trials with decentralized elements.

CGMP Violations at TJA Health

[ Price : $8.95]

FDA warns Joliet, IL-based TJA Health about CGMP violations in its manufacturing of finished drugs.

Quality CDMO Marketing Unapproved Drugs: FDA

[ Price : $8.95]

FDA warns Fort Worth, TX-based Quality CDMO that it is marketing five unapproved new drugs.