FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Kitov Pharma Planning NDA for Combo of 2 Pfizer Drugs

[ Price : $8.95]

Kitov Pharmaceuticals Holdings completes FDA-required stability testing on nine pivotal batches of KIT-302, which the company says...

Senate Passes Cures Act and Sends to Obamas Desk

[ Price : $8.95]

One week after the House passed the 21st Century Cures Act, the Senate votes 94 to 5 to pass the bill, and now sends it to Preside...

Mutual Reliance Initiative Expands Drug Inspections

[ Price : $8.95]

FDA associate commissioner Dana Corrigan says FDA is partnering with European Union regulatory authorities to expand drug manufact...

Senate Amendment Seeks to Prevent Generic Drug Delays

[ Price : $8.95]

Senate Judiciary Committee members led by ranking member Patrick Leahy (D-VT) introduce a bipartisan amendment to prevent pharmace...

Appeals Court Upholds Nexium Pay for Delay Decision

[ Price : $8.95]

Two Knobbe Martens attorneys outline reasons why a federal appeals court upheld a lower court jury ruling that a reverse payment t...

FDA Working with Stakeholders on Opioid Use: Throckmorton

[ Price : $8.95]

CDER deputy director Douglas Throckmorton says FDA is working well with stakeholders to achieve goals on the safe and appropriate ...

Regulators Look for Biosimilar Scientific Alignment: FDAer

[ Price : $8.95]

Office of New Drug associate director Leah Christl says that biosimilar companies should be aware of various regulators requiremen...

Latest FDA Warning Letters

[ Price : $8.95]

In its latest release of Warning Letters, FDA cites Interquim, a Spanish active pharmaceutical ingredient maker.

Class 2 for Computerized Concussion Assessment Aids

[ Price : $8.95]

Federal Register Final Order: FDA classifies Computerized Cognitive Assessment Aids for Concussion into Class II (special controls...

Biomarker Evidentiary Criteria Framework Released

[ Price : $8.95]

The Foundation for the National Institutes of Health issues its Framework for Defining Evidentiary Criteria for Biomarker Qualifi...