FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Vaccine Hesitancy Threatening Public Health: FDA

[ Price : $8.95]

FDA leaders say anti-vaxxers and those that are vaccine-hesitant due to safety concerns or religious beliefs are threatening U.S. ...

ModernaTX Hit with 483 Over GMPs

[ Price : $8.95]

FDA issues ModernaTX a five-item Form FDA-483 after a 09/11-21/2023 inspection documented GMP violations.

Rep. Murphy Wants FDA Artificial Intelligence Info

[ Price : $8.95]

Rep. Gregory Murphy asks FDA for its views on several aspects of using artificial intelligence in medical care as a prelude to reg...

Wound Dressing Change Kit Recalled

[ Price : $8.95]

ROi CPS of Republic, MO, recalls its Regard Wound Dressing change kit due to it containing nonconforming material/component.

Document on Guidance Best Practices

[ Price : $8.95]

Federal Register notice: FDA makes available a draft document entitled Food and Drug Administrations Draft Report and Plan on Best...

Latest Safety Signal Report Includes Ozempic, Others

[ Price : $8.95]

FDA says it is evaluating the need for regulatory action after seeing a safety signal for some additional side effects in GLP-1 re...

Siemens New MR Whole-Body Scanner Cleared

[ Price : $8.95]

FDA clears a Siemens Healthineers 510(k) for the MAGNETOM Cima.X 3 Tesla (3T) magnetic resonance imaging whole-body scanner.

Hold Lifted on Innate Lymphoma Trials

[ Price : $8.95]

FDA removes a partial clinical hold placed on Innate Pharma's Phase 2 TELLOMAK and Phase 1b PTCL trials of lacutamab in cutaneous ...

Consolidate Alternative Inspection Guidances: PhRMA

[ Price : $8.95]

PhRMA says FDA should consolidate its recent draft guidance on Remote Interactive Evaluations (RIE) of Drug Manufacturing and Bior...

ICH/EMA Viral Safety Guide Approved

[ Price : $8.95]

A European Medicines Agency committee has approved the International Council on Harmonizations Guidelines on viral safety evaluati...