FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Genentech Phase 3 Actemra Trial for Coronavirus

[ Price : $8.95]

FDA green lights a Genentech randomized, double-blind, placebo-controlled Phase 3 clinical trial in collaboration with the Biomedi...

FDA Permanently Debars Kalinoski on Filthy Drugs

[ Price : $8.95]

Federal Register notice: FDA permanently debars Stephen Kalinoski from providing services in any capacity to a person that has an ...

Tighe Permanently Debarred by FDA

[ Price : $8.95]

Federal Register notice: FDA permanently debars Gerald Tighe from providing services related to an approved or pending drug produc...

Edwards Permanently Debarred by FDA

[ Price : $8.95]

Federal Register notice: FDA permanently debars Brenda Elise Edwards from providing services in any capacity to a person that has ...

2 Guidances on Making Hand Sanitizers

[ Price : $8.95]

FDA issues two guidance documents to communicate its policy for temporary manufacturing of certain alcohol-based hand sanitizer pr...

FDA Clears Remote Monitors Temporary Expanded Use

[ Price : $8.95]

FDA issues a new policy that allows manufacturers of certain FDA-cleared vital sign-measuring devices to expand their use for heal...

Some Adverse Event Reporting Relaxed Under Pandemic

[ Price : $8.95]

FDA issues a guidance entitled Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemi...

FDA Update on Painkillers Worsening Virus

[ Price : $8.95]

After gaining some media attention, a new FDA safety update says it is not aware of scientific evidence connecting the use of NSAI...

FDA Rejects Boehringer/Lilly Diabetes NDA

[ Price : $8.95]

FDA sends Boehringer Ingelheim and Eli Lilly a complete response letter on a supplemental NDA New Drug Application (sNDA) for empa...

Guide on Cigarette Warnings

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Required Warnings for Cigarette Packages and Advertisements...