FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

PBPK Analyses Draft Guidance Out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FDA issues a draft guidance on using PBPK analyses for some biopharmaceutics applications.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....

Redesigned Sentinel Initiative Web Site Launched

[ Price : $8.95]

FDA launches its redesigned Sentinel Initiative Web site to increase organization and usability.

CardioQuip Cooler/Heater Tied to Infections

[ Price : $8.95]

FDA says it has learned of three patients from one facility who were infected after undergoing cardiothoracic surgery involving th...

Marks Says Covid Vaccine Makers Know Data Expectations

[ Price : $8.95]

CBER director Peter Marks says vaccine makers already know data recommendations outlined in a proposed guidance currently on hold ...

Woodcock Sees Clinical Trials Deteriorating Under Covid

[ Price : $8.95]

CDER director Janet Woodcock says the Covid-19 pandemic has led to a further deterioration in the U.S. clinical trials system.

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Federal Register notice: FDA makes available a draft guidance entitled M7 Assessment and Control of DNA Reactive (Mutagenic) Impur...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Federal Register notice: FDA makes available a draft guidance entitled Failure to Respond to an ANDA Complete Response Letter With...