FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Boxed Warning for Bowel Cleansing Products

[ Price : $8.95]

FDA orders a boxed warning on labeling for two prescription bowel cleansing products due to risk of a type of kidney injury.

Guidance on OTC Drug Labeling

[ Price : $8.95]

Federal Register Notice: FDA releases a revised draft guidance on the labeling of nonprescription human drugs products marketed wi...

FDA OKs Ivy Labs sANADA

[ Price : $8.95]

Federal Register Final rule: FDA approves an Ivy Labs sANADA for increased levels of monensin in Type C medicated feeds for heifer...

Why Did FDA Wait 6 Months to Seize Bad Heparin?

[ Price : $8.95]

Rep. Barton asks why FDA waited six months to seize contaminated heparin after twice warning the manufacturer that its recall effo...

PhRMA Issues Strengthened DTC Principles

[ Price : $8.95]

PhRMA revises its DTC Guiding Principles and will release names of companies promising to comply.

FDA Panel Backs Genzymes Synvisc-One

[ Price : $8.95]

An FDA advisory committee recommends approval of Genzymes Synvisc-One, intended for use in relieving pain associated with osteoart...

Advisors Nix Acuspheres Imagify

[ Price : $8.95]

FDAs Cardiovascular and Renal Drugs Advisory Committee says Acuspheres Imagify doesnt offer enough benefit to overcome its risks....

2 Clinical Trial Withdrawal Guidances

[ Price : $8.95]

FDA and HHS issue guidances on use of data when a subject is no longer participating in a clinical trial.

PMA Supplement Guidance Out

[ Price : $8.95]

CDRH issues a guidance to help sponsors determine the type of regulatory submission needed to modify a lawfully marketed PMA devic...

Commissioner Should Have No Industry Ties: Professor

[ Price : $8.95]

Boston University professor Alan Cohen says the Obama administration should appoint an FDA commissioner who has no ties to any reg...