FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

AstraZenecas Voydeya OKd for Hemolysis

[ Price : $8.95]

FDA approves AstraZenecas Voydeya (danicopan) as an add-on therapy to Ultomiris (ravulizumab) or Soliris (eculizumab) for treating...

Eisai sBLA for Monthly Alzheimers Maintenance

[ Price : $8.95]

Eisai files a supplemental BLA for monthly Leqembi (lecanemab-irmb) intravenous maintenance dosing in Alzheimers disease patients....

FDA Guide on Safety Report e-Submissions

[ Price : $8.95]

FDA posts a final guidance entitled Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies.

IND Safety Report eSubmissions Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Providing Regulatory Submissions in Electronic Format: IND ...

FDA Clears Abbotts Concussion Blood Test

[ Price : $8.95]

FDA clears Abbotts i-STAT TBI (traumatic brain injury) cartridge to be used with whole blood to assess patients with suspected con...

PhRMA Seeks Specificity for Cell Product Potency Guide

[ Price : $8.95]

Pharmaceutical Research and Manufacturers of America says FDAs recent draft guidance on cell and gene therapy potency assurance ne...

FDA Clears Digital Therapeutic for Depression

[ Price : $8.95]

FDA clears an Otsuka Pharmaceutical and Click Therapeutics 510(k) for Rejoyn, a prescription digital therapeutic authorized for tr...

Guide on Dental Bone Grafting Devices

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Animal Studies for Dental Bone Grafting Material Devices P...

Thoratec Recalls HeartMate Touch Communication

[ Price : $8.95]

Thoratec recalls its HeartMate Touch Communication System due to software design issues.

eSTAR Now Available for Device 513(g) Requests

[ Price : $8.95]

FDA says its electronic Submission Template And Resource system is now available for voluntary 513(g) (device classification) requ...