FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Republicans Reopen Opioid Manufacturer Probe

[ Price : $8.95]

House Energy and Commerce Committee Republican leaders say they are renewing a 2018 investigation into three opioid manufacturers ...

FDA Alert on Eisai Weight-loss Drug

[ Price : $8.95]

A new FDA safety alert says that results from a clinical trial assessing safety of Eisais weight-loss drugs Belviq and Belviq XR (...

Partial Clinical Hold on Innates Lacutamab

[ Price : $8.95]

FDA places a partial clinical hold on Innate Pharmas TELLOMAK Phase 2 trial that is evaluating lacutamabs efficacy and safety in p...

CDER Priorities: Postmarket Safety and New Drugs Program

[ Price : $8.95]

CDER director Janet Woodcock says enhancing postmarket safety initiatives and modernizing the Centers new drugs regulatory program...

510(k) Preemption for Powered Wheeled Stretchers

[ Price : $8.95]

Federal Register notice: FDA exempts powered wheeled stretchers from premarket notification (510(k)) requirements.

Draft Guide on PTA/Specialty Catheters

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Peripheral Percutaneous Transluminal Angioplasty (PTA) and ...

Taro Recalls 1 Lot of Contaminated Lamotrigine

[ Price : $8.95]

Taro Pharmaceuticals recalls one lot of epilepsy/bipolar drug lamotrigine 100 mg tablets after it was found to have been cross-con...

Aidoc AI Stroke Detection Module Cleared

[ Price : $8.95]

FDA clears an Aidoc 510(k) for its artificial intelligence component for flagging large-vessel occlusion in head computed tomograp...

Galemed Recalls Infant Breathing Manifold

[ Price : $8.95]

Galemed recalls (Class 1) its Babi.Plus Pressure Relief Manifold system due to complaints about the device not holding pressure.

FDA Accepts Re-filed NDA for Acromegaly Drug

[ Price : $8.95]

FDA accepts for review a Chiasma NDA resubmission for Mycapssa (octreotide) capsules for the maintenance treatment of adults with ...