FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Lantern Pharma Gets Orphan Status LP-184

[ Price : $8.95]

FDA grants Lantern Pharma an orphan drug designation for LP-184 and its use in treating glioblastoma multiforme and other malignan...

EUA Withdrawn for Curative Covid Assay

[ Price : $8.95]

Federal Register notice: FDA announces that it has revoked the Emergency Use Authorization issued to Curative Inc. for its Curativ...

2 Guides on Device Performance Based Pathway

[ Price : $8.95]

Federal Register notice: FDA makes available two draft device-specific guidance documents for the Safety and Performance Based Pat...

Breckenridges Solifenacin Succinate ANDA Withdrawn

[ Price : $8.95]

Federal Register notice: FDA withdraws the approval of a Breckenridge Pharmaceutical ANDA for solifenacin succinate tablets (5mg a...

CDER Promotional eSubmission Validation Errors

[ Price : $8.95]

Federal Register notice: CDER announces that 10/18 is the effective date that it will begin rejecting submissions that fail either...

Guide on Facet Screw Systems Performance Criteria

[ Price : $8.95]

FDA posts a draft guidance entitled Facet Screw Systems Performance Criteria for Safety and Performance Based Pathway.

Guide on Denture Resin Performance Criteria

[ Price : $8.95]

FDA posts a draft guidance entitled Denture Base Resins Performance Criteria for Safety and Performance Based Pathway.

Study Confirms Cell Phone Magnetic Interference

[ Price : $8.95]

A new study by FDA researchers supports an agency recommendation earlier this year that patients keep any consumer electronic devi...

FDA OKs Vagus Nerve Stimulation for Stroke Patients

[ Price : $8.95]

FDA approves a MicroTransponder PMA for the Vivistim Paired VNS System, a vagus nerve stimulation device intended to treat moderat...

Roche Drops Tecentriq Breast Cancer Indication

[ Price : $8.95]

Roche withdraws its accelerated approval for Tecentriq (atezolizumab) in combination with chemotherapy for treating adults with un...