FDA Issues Draft Guidance on PBPK Analysis
US regulatory authority Food and Drug Administration (FDA) on 1st December 2016 released a new draft guidance designed to assist
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Erelzi Gets Approval from FDA, a Biosimilar to Enbrel
The US Food and Drug Administration on 30th August accepted Sandoz’s biosimilar to Amgen’s blockbuster Enbrel, which will be identified
Read morePfizer’s Chantix Not Associated To Serious Psychiatric Side Effects: A Global Study Finds Smoking Cessation Drugs Deemed Safe
It is a known fact that in 2009 US FDA kept black box warning for Pfizer’s stop smoking drug Chantix.
Read moreFDA Shares Thoughts on Young Animal Studies for Cancer Drugs
According to an article published recently, officers from the US Food and Drug Administration (FDA) say that studies looking at
Read moreHalaven Gets Green Light from US FDA to Treat Liposarcoma
The U.S. Food and Drug Administration has accepted Halaven (Eribulin Mesylate), a kind of chemotherapy, for the therapy of liposarcoma
Read moreFDA Stated that Pharmas May Need to Repeat tests as CRO Cetero has Fabricated Trial Data
According to the US FDA, Cetero Research, a North Carolina based CRO, allegedly produced fake clinical trial documents and test
Read moreFDA to Employ a Different Process for Approval of Generic Drugs
The FDA calls for a shortened approval process for Generic drugs. However, because of the enormously high number of applications
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