FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Guidance on Total Kidney Volume Biomarker

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance on Qualification of Biomarker Total Kidney Volume in Studies for Treatment of Au...

Guidance on Gene Therapy Microbial Vector Recommendations

[ Price : $8.95]

Federal Register Notice: FDA posts a guidance on Recommendations for Microbial Vectors Used for Gene Therapy that provides recomme...

Guidance on Animal Drug Bioequivalence Waivers

[ Price : $8.95]

Federal Register Notice: FDA releases a revised guidance for industry (#171) on Waivers from the Requirement to Demonstrate Bioequ...

Workshop on Coordinated Antibiotic, Related Test Development

[ Price : $8.95]

Federal Register Notice: FDA plans a public workshop on Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptib...

Medtronic Drug-coated Balloon OK'd for In-stent Restinosis

[ Price : $8.95]

FDA approves a Medtronic PMA for the IN.PACT Admiral drug-coated balloon for treating in-stent restenosis in patients with periphe...

Advisors Want Chantix Boxed Warning Pulled

[ Price : $8.95]

A bare majority of members of two FDA advisory committees say the agency should remove a Boxed Warning on neuropsychiatric adverse...

Plasma Fibrinogen Biomarker Guidance

[ Price : $8.95]

FDA issues a guidance with a context of use for the biomarker plasma finrinogen in COPD clinical trials.

Bipartisan Drug Pricing Legislation

[ Price : $8.95]

Two senators and a representative introduce legislation to mandate reporting of some pending drug price increases to HHS.

FDA Approved Aralez NDA for Cardiovascular Drug

[ Price : $8.95]

FDA approves an Aralez Pharmaceuticals NDA resubmission for Yosprala (aspirin and omeprazole), indicated for the secondary prevent...

FDA Extends Review of Lexicon NDA for Carcinoid Syndrome

[ Price : $8.95]

FDA extends by three months its review of a Lexicon Pharmaceuticals NDA for telotristat etiprate, an oral drug for treating carcin...