FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Vision Patient-reported Outcomes Workshop

[ Price : $8.95]

FDA announces a 9/29 virtual public workshop entitled Patient-Reported Outcomes and Vision-Related Quality of Life Questionnaires....

Novo Nordisk Gets FDA-483: Reports

[ Price : $8.95]

FDA reportedly issues Novo Nordisk a Form FDA-483 that cites GMP deficiencies at its Clayton, NC, manufacturing plant, which is a ...

Reverse Osmosis Dialysis Water Device Cleared

[ Price : $8.95]

FDA clears a B. Braun Medical 510(k) for its AQUAbase nX Reverse Osmosis System for providing high-quality water for dialysis pati...

Verona NDA for COPD Drug Accepted

[ Price : $8.95]

FDA accepts for review a Verona Pharma NDA for ensifentrine for the maintenance treatment of patients with chronic obstructive pul...

Draft Guide on Biosimilar Prescribing Info

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Labeling for Biosimilar and Interchangeable Biosimilar Prod...

Draft Guide on Biosimilar/Interchangeable Labeling

[ Price : $8.95]

FDA posts a draft guidance entitled Labeling for Biosimilar and Interchangeable Biosimilar Products.

FDA Extends BLA Review of Melanoma Therapy

[ Price : $8.95]

FDA extends by 90 days its review of an Iovance Biotherapeutics BLA submission for lifileucel, a tumor infiltrating lymphocyte the...

Guide on Drug Postmarketing Submissions

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Annual Status Report Information and Other Submissions for ...

2 Draft Guides on Weight Loss Devices

[ Price : $8.95]

Federal Register notice: FDA makes available two draft guidances on clinical and non-clinical study recommendations for medical de...

Final Guide on Device Improvement Program

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Fostering Medical Device Improvement: Food and Drug Adminis...