FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

12 No-Longer-Marketed ANDAs Withdrawn

[ Price : $8.95]

Federal Register notice: FDA withdraws approval of 12 ANDAs from multiple applicants after they notified the agency that they were...

Test Emergency Policies Under Sec. 564 Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Consideration of Enforcement Policies for Tests During a Se...

FDA Clears ZygoFix Spinal Fusion Alternative

[ Price : $8.95]

FDA clears a ZygoFix 510(k) for its zLOCK Lumbar Facet Fixation System an implant that adapts to the joint's anatomy during insert...

Lyric Hearing Aid Cleared for Self Replacement

[ Price : $8.95]

FDA clears a Phonak 510(k) for its Phonak Lyric hearing aid and a self-replacement option to reduce office visits.

FDA Debars Runsdorg Over Cough Syrup

[ Price : $8.95]

Federal Register notice: FDA issues an order permanently debarring Adam Paul Runsdorf over his felony conviction for conspiring to...

CDER Launches Quantitative Medicine Center

[ Price : $8.95]

CDER launches a new Quantitative Medicine Center of Excellence to help streamline and accelerate drug development.

Veterinary Pharmaceutical Development Draft Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a veterinary-use draft guidance entitled #290 (VICH GL61) Pharmaceutical Development....

WSJ Apologizes for Supporting Califf

[ Price : $8.95]

An unusually strident Wall Street Journal editorial apologizes to its readers for supporting FDA commissioner Robert Califfs appoi...

Dupixent COPD sBLA May Face Review Delay

[ Price : $8.95]

Regeneron faces a potential approval delay on its supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatment in ...

Bill to Restrict Revolving Door When FDAers Depart

[ Price : $8.95]

A just-introduced bill, Fixing Administrations Unethical Corrupt Influence Act, restricts top federal health officials at FDA, CDC...