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Guidances on Adjuvant Treatments for Renal, Bladder Cancer

[ Price : $8.95]

FDA publishes guidances on developing drugs and biologics for adjuvant treatment of two types of cancer.

Guide on Using Physiologically Based Pharmacokinetic Analyses

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled The Use of Physiologically Based Pharmacokinetic Analyses ...

Draft Guide on QT Prolongation Evaluation Q&As

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc I...

AndroGel Case Remanded to Pennsylvania Federal Court

[ Price : $8.95]

The 3rd Circuit Court of Appeals says a Pennsylvania federal court erred in portions of its decision in a case involving AndroGel ...

Drug Company Profits Push Prices: Reports

[ Price : $8.95]

Two House Oversight Committee reports say excessive drug company profits are the primary driver of higher prescription drug prices...

Court Questions Criminalizing Off-Label Promotion

[ Price : $8.95]

Attorney Stephen McConnell says the Massachusetts federal court is calling for Congress and FDA to reconsider the statutory and re...

Clinical Hold on Gene Therapy Lifted

[ Price : $8.95]

FDA lifts a clinical hold against Solid Biosciences IGNITE DMD Phase 1/2 clinical trial involving SGT-001, a novel adeno-associate...

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...

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.