Ranbaxy’s Ripples: Generic Drug Integrity Returns As Focus For Congress, FDA
Executive Summary
Problems at a drug company have once again put FDA in the crosshairs of the House Energy and Commerce Committee
You may also be interested in...
Ranbaxy’s First-To-File ANDAs At Risk In FDA Data Integrity Probe
Several first-to-file ANDAs are on the line for Ranbaxy as it tries to resolve data integrity issues at its Paonta Sahib facility with FDA
Ranbaxy’s First-To-File ANDAs At Risk In FDA Data Integrity Probe
Several first-to-file ANDAs are on the line for Ranbaxy as it tries to resolve data integrity issues at its Paonta Sahib facility with FDA
FDA Revisits Wellbutrin Generics – Again; Will Teva Fund A High-Dose Study?
As FDA considers how best to address continued concerns about generics for Wellbutrin XL (bupropion extended-release tablets), one issue it may wrestle with is whether it should conduct bioequivalence studies at the highest dose, 300 mg, which has a higher risk of seizures