FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Nuvation Bio Phase 1 Trial Hit with Clinical Hold

[ Price : $8.95]

FDA places a partial clinical hold on a Nuvation Bio Phase 1 dose escalation study of NUV-422 in solid tumors after receiving repo...

Vaccines Panel Mulls Omicron Boosters

[ Price : $8.95]

FDAs Vaccines and Related Biological Products Advisory Committee meets to discuss whether and how the SARS-CoV-2 strain compositio...

Innovative Trial Design Work Highlighted in CDER Report

[ Price : $8.95]

A new CDER Office of New Drugs annual report highlights some of its work with sponsors to advance innovative clinical trial design...

Nasal Spray Film Cleared for Allergic Rhinitis

[ Price : $8.95]

FDA clears an Altamira Therapeutics 510(k) to market its nasal spray Bentrio for treating allergic rhinitis.

Acutus Expands Left-Heart Access Devices

[ Price : $8.95]

FDA clears an Acutus Medical 510(k) for an expanded suite of left-heart access products to include the AcQCross Qx system for use ...

Guide on Oligonucleotide Drug Development

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Clinical Pharmacology Considerations for the Development of...

AbbVie sNDA for Qulipta to Prevent Chronic Migraine

[ Price : $8.95]

AbbVie submits an sNDA for Qulipta as a preventive treatment for chronic migraine.

Amryt Seeking Dispute Resolution on Filsuvez NDA

[ Price : $8.95]

Amryt seeks FDA formal dispute resolution over a complete response letter it received in February for its NDA for Filsuvez (oleoge...

Ex-Pharmatech CEO Pleads Guilty to Defrauding FDA

[ Price : $8.95]

Former Pharmatech CEO Raidel Figueroa pleads guilty to conspiring to defraud FDA, among other charges, in a case involving contami...

Alternate e-Format Guide for Drugs/Biologics

[ Price : $8.95]

FDA makes available a guidance entitled Providing Regulatory Submissions in Alternate Electronic Format.