FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Working on Pediatric Renal Function Models

[ Price : $8.95]

CDER says its scientists are investigating how to improve pediatric dose selection by predicting drug clearance from renal functio...

FDA Software Functions Guidance Explained

[ Price : $8.95]

Two Hyman, Phelps medical device technical experts review provisions in a new FDA draft guidance on medical device software premar...

House Covid Committee Wants Info from Hahn

[ Price : $8.95]

The House Select Committee on Covid-19 asks former FDA commissioner Stephen Hahn for documents and an interview on Trump administr...

Fast Track for Colorectal Cancer Folate Drug

[ Price : $8.95]

FDA grants Isofol Medical a fast track designation for arfolitixorin, a stabilized and biologically active pure form of folate ([6...

Califf Financial Disclosures Show Millions from Industry

[ Price : $8.95]

New financial disclosure documents show Robert Califf earned millions of dollars last year from industry, which could disrupt the ...

Groundbreaking Benefit/Risk Assessment Guidance Outlined

[ Price : $8.95]

Four Sidley attorneys see significant regulatory change in a new FDA draft guidance on benefit/risk expectations for drug developm...

FDA Reclassifies 3 Blood Lancets

[ Price : $8.95]

Federal Register notice: FDA issues a final order to reclassify three types of blood lancets used to puncture skin to obtain a dro...

Hep C Virus Antibody Assays Reclassified

[ Price : $8.95]

Federal Register notice: FDA issues a final order to reclassify certain hepatitis C virus (HCV) antibody assay devices intended fo...

Hep C virus RNA Devices Reclassified

[ Price : $8.95]

Federal Register notice: FDA issues a final order to reclassify nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) ...

Comments Extended on Sunscreen OTC Monograph

[ Price : $8.95]

Federal Register notice: FDA extends the comment period for a 9/24 over-the-counter monograph proposed order until 12/27.