FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Welldoc 510(k) for BlueStar Insulin Adjustment

[ Price : $8.95]

FDA clears a Welldoc 510(k) to add a new feature to its digital health product BlueStar Rx which supports individuals using long-a...

FDA Drug Competition Plan Hurts Investors: Motley Fool

[ Price : $8.95]

The Motley Fool says FDAs drug competition initiative to promote generic drugs is good for consumers but can hurt some investors.

Noctrix Breakthrough Device for Restless Legs Syndrome

[ Price : $8.95]

FDA grants Noctrix Health a Breakthrough DevicR-CASEe Designation for its wearable NTX100 neuromodulation therapy designed for tre...

New Diabetes Draft Guidance is Step Backward: Professor

[ Price : $8.95]

Two stakeholders comment on an FDA draft guidance on evaluating the safety of new drugs for improving glycemic control.

Physician Group Sues FDA for Hydroxychloroquine Access

[ Price : $8.95]

The Association of American Physicians and Surgeons files suit against FDA in western Michigan federal court to force the agency t...

Modeling Tools to Aid Generic Drug Development

[ Price : $8.95]

An FDA Regulatory Science Impact Story article touts the use of quantitative methods and modeling to modernize generic drug develo...

CytoDyn BLA for Leronlimab in HIV

[ Price : $8.95]

CytoDyn files a BLA for Pro 140 (leronlimab (PRO 140) for use in combination therapy for treating HIV infection.

Translating In Vitro Antiviral Activity in Covid Drugs

[ Price : $8.95]

A CDER online post stresses the need for accurate in vitro to in vivo translation of data as part of new drug development to treat...

Safety Alert on Mislabeled Paralyzing Agents

[ Price : $8.95]

An FDA-issued safety alert warns health care professionals about the temporary absence of a paralyzing agent warning statement on ...

Covid IRB Expanded Access Guidance

[ Price : $8.95]

FDA issues an immediately-in-effect guidance on IRB procedures and factors to consider for individual patient expanded access requ...