FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Covid Global Partnering Explained

[ Price : $8.95]

An FDA online paper explains how the agency is leveraging its international collaboration activities to help respond to the Covid-...

Medtronic PMA Approved for Brain Stimulation

[ Price : $8.95]

FDA approves a Medtronic PMA for the Percept PC Deep Brain Stimulation system for treating patients with neurologic disorders asso...

Feds Should Make Covid Vaccine Affordable to All: Report

[ Price : $8.95]

Public Citizen says the federal government should use its interest in patents shared with Moderna for a Covid-19 vaccine candidate...

Mercks Keytruda OKd for Cell Carcinoma

[ Price : $8.95]

FDA approves Mercks Keytruda (pembrolizumab) as monotherapy for treating patients with recurrent or metastatic cutaneous squamous ...

Guide on Developing Pneumonia Drugs

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Community-Acquired Bacterial Pneumonia: Developing Drugs fo...

Guide on Hospital/Ventilator-related Pneumonia

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Hospital-Acquired Bacterial Pneumonia and Ventilator-Associ...

Interpreting Sameness Guidance Helpful: BIO

[ Price : $8.95]

BIO says an FDA draft guidance on interpreting gene therapy product sameness is helpful and asks that the agency state that the dr...

Questions on Emergency-Use Injector Guidance

[ Price : $8.95]

Three stakeholders raise concerns about an FDA draft guidance on technical considerations to show the reliability of emergency-use...

FDA Lessons for Managing Data Better

[ Price : $8.95]

CDERs Shanthi Vigneshwaran discusses the Centers years of work to make its voluminous data more useable.

FDA, Duke Hold Meeting on Real-world Data

[ Price : $8.95]

FDA and the Duke-Margolis Center for Health Policy announce a 7/13-14 virtual public meeting to explore potential approaches to de...