FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Appeals Court Reverses Ivermectin Suit Dismissal

[ Price : $8.95]

The 5th Circuit Court of Appeals overrules a Texas federal court and says a suit by three doctors against FDA and HHS and their to...

Techsomed Ablation Planning Software Cleared

[ Price : $8.95]

FDA clears a Techsomed 510(k) for its VisAble.IO software intended to assist physicians in planning liver ablation procedures and ...

CGMP Violations at Lex, Inc.

[ Price : $8.95]

FDA warns Medley, FL-based Lex, Inc., about repeat CGMP violations in its production of finished drugs as a contract facility.

Mycobacterial Pulmonary Disease Draft Guide

[ Price : $8.95]

Federal Register notice: FDA publishes a draft guidance entitled Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobact...

Generic Drug Warning Letter Meetings Guide

[ Price : $8.95]

Federal Register notice: FDA posts a draft guidance entitled Post-Warning Letter Meetings Under GDUFA.

35 No-Longer-Marketed NDAs Withdrawn

[ Price : $8.95]

Federal Register notice: FDA withdraws 35 no-longer-marketed NDAs from multiple applicants.

Meeting on Reauthorizing OTC Drug User Fees

[ Price : $8.95]

Federal Register notice: FDA announces a public meeting to discuss proposed recommendations for the reauthorization of the Over-th...

Green Pharma Warned Over CGMP Issues

[ Price : $8.95]

FDA warns South Koreas Green Pharmaceutical Co. in Jincheon about CGMP violations in its manufacturing of over-the-counter drugs.

Interoperable Info Exchange Guidance

[ Price : $8.95]

FDA publishes an updated guidance on standards for the interoperable exchange of information for tracing certain drugs under the D...

Emergency Preparedness Supply Chain

[ Price : $8.95]

FDA posts recommendations for healthcare providers, medical device manufacturers, and distributors on best practices in preparing ...