FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

CDER Wants Info for Kidney Safety Biomarker Pilot

[ Price : $8.95]

An FDA Federal Register notice requests information from drug developers and academic investigators to support a pilot project foc...

Ipsen Pulls Tazverik Due to Secondary Blood Cancer Risk

[ Price : $8.95]

Ipsen withdraws its cancer drug Tazverik (tazemetostat) from the U.S. market after new clinical trial data showed an increased ris...

FDA Cites SCA Pharmaceuticals Over Sterility, Contamination Control

[ Price : $8.95]

A March inspection of SCA Pharmaceuticals cites multiple manufacturing and contamination-control deficiencies at its outsourcing f...

Ashirwad Hospital Bioresearch Monitoring Issues

[ Price : $8.95]

FDA warns Indias Ashirwad Hospital Center and clinical investigator Mukesh Chandre about failing to obtain informed consent for a ...

Staska Pharma Hit with FDA Form 483

[ Price : $8.95]

An FDA inspection cites multiple quality control and aseptic processing concerns at Staska Pharmaceuticals.

FDA Guide on Developing Drugs for Pulmonary Tuberculosis

[ Price : $8.95]

FDA posts updated guidance outlining how drugmakers should design clinical development programs for new tuberculosis treatments, e...

FDA Delays Review Action on Alzheimers Drug

[ Price : $8.95]

FDA delays by three months its decision on Eisai and Biogen's subcutaneous starting-dose formulation of Alzheimers drug Leqembi (l...

Legal Analysis Highlights Impact of FDA AI Clinical Trial Pilot

[ Price : $8.95]

A legal analysis published by Crowell & Moring says a proposed FDA pilot program on artificial intelligence in early-stage clinica...

Trump Denies Makary is on the Outs

[ Price : $8.95]

President Trump tells reporters he knows nothing about reports suggesting FDA commissioner Marty Makary will be asked to resign so...

FDA Input Sought on Drug Repurposing

[ Price : $8.95]

FDA seeks public input on ways to expand drug repurposing efforts, aiming to accelerate treatment options for patients with unmet ...