FDA Issues Draft Guidance on PBPK Analysis
US regulatory authority Food and Drug Administration (FDA) on 1st December 2016 released a new draft guidance designed to assist
Read moreUS regulatory authority Food and Drug Administration (FDA) on 1st December 2016 released a new draft guidance designed to assist
Read moreThe US Food and Drug Administration on 30th August accepted Sandoz’s biosimilar to Amgen’s blockbuster Enbrel, which will be identified
Read moreIt is a known fact that in 2009 US FDA kept black box warning for Pfizer’s stop smoking drug Chantix.
Read moreAccording to an article published recently, officers from the US Food and Drug Administration (FDA) say that studies looking at
Read moreThe U.S. Food and Drug Administration has accepted Halaven (Eribulin Mesylate), a kind of chemotherapy, for the therapy of liposarcoma
Read moreAccording to the US FDA, Cetero Research, a North Carolina based CRO, allegedly produced fake clinical trial documents and test
Read moreThe FDA calls for a shortened approval process for Generic drugs. However, because of the enormously high number of applications
Read more