FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Clinical Trial Oversight Slipping: Report

[ Price : $8.95]

A review of FDA inspection documents by the journal Science on the agencys clinical trial oversight during the past 11 years shows...

Draft Guide on Drug Mutagenic Impurities

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled M7 Assessment and Control of DNA Reactive (Mutagenic) Impur...

Guide on ANDA Complete Response Letters

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Failure to Respond to an ANDA Complete Response Letter With...

Final guide on Breast Implant Labeling

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance on Breast Implants Certain Labeling Recommendations to Improve Pati...

Political Intrusion Prolongs the Pandemic: Op-Ed

[ Price : $8.95]

Seven former FDA commissioners call on the White House to let FDA do its scientific work without political interference.

Covid Reference Panel Comparative Data Updated

[ Price : $8.95]

FDA updates the SARS-CoV-2 reference panel comparative data.

PBPK Analyses Draft Guidance Out

[ Price : $8.95]

FDA issues a draft guidance on using PBPK analyses for some biopharmaceutics applications.

Catalyst to Appeal Loss in Firdapse Orphan Drug Case

[ Price : $8.95]

Catalyst says it will appeal a Florida federal court ruling dismissing its case against FDA over orphan drug exclusivity for Firda...

Vaccine Advisory Committee Amendment Notice

[ Price : $8.95]

Federal Register notice: FDA announces an amendment to a 10/22 Vaccines and Related Biological Products Advisory Committee meeting...

Public Meeting on Stimulant Use Disorder

[ Price : $8.95]

Federal Register notice: FDA announces a 10/6 public meeting entitled Patient-Focused Drug Development for Stimulant Use Disorder....