FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Sees Challenges in Condoliase BLA

[ Price : $8.95]

FDA asks members of its Anesthetic and Analgesic Drug Products Advisory Committee to discuss several challenges the agency has ide...

Vanda Criticizes FDA Over Drug Rejection

[ Price : $8.95]

Vanda Pharmaceuticals criticizes FDA for failing to approve the companys NDA for tradipitant to treat the symptoms of gastroparesi...

5 Repeat CGMP Violations at Indoco Remedies

[ Price : $8.95]

FDA warns Indias Indoco Remedies about repeat CGMP violations in its production of finished drugs.

FDA Obesity/Overweight Drug Development Guide

[ Price : $8.95]

FDA publishes a draft guidance with recommendations on clinical trials for drugs and biologics to treat obesity and overweight.

Off-Label Communications Q&A Guide

[ Price : $8.95]

FDA issues a guidance finalizing a 2023 draft document on communicating scientific information on unapproved uses of approved or c...

Rybrevant/Lazcluze Cancer Study Positive: J&J

[ Price : $8.95]

Johnson & Johnson says its Phase 3 MARIPOSA study showed that its Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) had a st...

Jiao Debarment Notice Corrected

[ Price : $8.95]

Federal Register notice: FDA corrects a 12/5/2024 debarment notice against Yong Sheng Jiao (also known as Yongsheng Jiao and Wilso...

2 ALS Drugs Miss Endpoints

[ Price : $8.95]

Denali Therapeutics and Calico Life Sciences say their two eukaryotic initiation factor 2B activator drugs each failed to meet pri...

Lifecycle Recommendations for AI-Enabled Devices

[ Price : $8.95]

FDA publishes a draft guidance with recommendations on lifecycle management and marketing submissions for AI-enabled medical devic...

Sex Differences in Clinical Evaluations of Products

[ Price : $8.95]

FDA publishes a draft guidance intended to improve the representation of females in medical product clinical trials.