FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Draft Guide on Bowel Cleansing Products

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Bowel Cleansing for Colonoscopy: Efficacy and Safety Consid...

Pediatric Anti-infective Drug Guidance

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Development of Anti-Infective Drug Products for the Pediatr...

Impurities Guide on Residual Solvents

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance for industry entitled Q3C (R8) Impurities: Guidance for Residual Sol...

House Report Slams Drug Pricing, Patent Manipulating

[ Price : $8.95]

A U.S. House Oversight and Reform Committee staff report alleges troubling issues with drug companies rising prices and actions to...

Urotronic PMA Approved for Urethral Strictures

[ Price : $8.95]

FDA approves an Urotronic PMA for Optilume Urethral Drug Coated Balloon for use in male urethral strictures.

FDA Panel Knocks Down Ischemic Stroke Device

[ Price : $8.95]

An FDA advisory committee votes 7 to 3 that a BrainsGate PMA for its Ischemic Stroke System did not demonstrate that the devices b...

Comments Extended on Real-World Data Guide

[ Price : $8.95]

Federal Register notice: FDA reopens the comment period on a draft guidance entitled Real-World Data: Assessing Electronic Health ...

Info Collection on Drug Label Requirements

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection revision entitled Labeling Requirements for Prescription Drugs...

Final Guide on Reporting Biologic CMC Changes

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled CMC Postapproval Manufacturing Changes for Specified Biolog...

Guide on ANDA Cover Letter Attachments

[ Price : $8.95]

FDA posts a draft guidance entitled Cover Letter Attachments for Controlled Correspondences and ANDA Submissions.