FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Senate Judiciary Committee Clears 5 Drug Bills

[ Price : $8.95]

The Senate Judiciary Committee clears five drug-related bills that would prohibit brand manufacturers from blocking/delaying gener...

GSKs Jemperli Gets OK for Endometrial Cancer

[ Price : $8.95]

FDA grants full approval to GSKs Jemperli (dostarlimab-gxly) for certain adult patients with mismatch repair deficient (dMMR) recu...

Tahsildar Debarred for 2 Years Over Canadian Drugs

[ Price : $8.95]

Federal Register notice: FDA issues an order debarring Hassan Tahsildar for two years from providing services to a person that has...

CBER in a Transition Year: Marks

[ Price : $8.95]

CBER director Peter Marks says the Center is recruiting 125 new staff to work on cell and gene therapies during a transitional 202...

EUA for BD Combination Covid-Flu-RSV Test

[ Price : $8.95]

FDA grants an emergency use authorization for a BD molecular test that differentiates between Covid-19, the flu, and RSV.

FDA Unsure of Unprecedented Jemperli Trial Plans

[ Price : $8.95]

FDA medical reviewers raise concerns about GlaxoSmithKlines proposed trials of Jemperli to support a future BLA accelerated approv...

Industry VMSR Improvement Suggestions

[ Price : $8.95]

Two medical device associations suggest ways to improve an FDA draft guidance on the Voluntary Malfunction Summary Reporting progr...

CDER Researches Convolutional Neural Networks

[ Price : $8.95]

CDER describes a research study using flow microscopy and convolutional neural networks to monitor changes in product quality attr...

DiA Imagings AI Imaging Software Cleared

[ Price : $8.95]

FDA clears a DiA Imaging Analysis 510(k) for its LVivo IQS, a new artificial intelligence-based vendor-neutral software intended t...

Universal Meditech Recalls Covid Tests

[ Price : $8.95]

Universal Meditech recalls (Class 1) its Skippack Medical Lab Covid-19 Direct Antigen Rapid Tests (Colloidal Gold) because they di...