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Clinical Research Society

Clinical Research Society

International Society for Clinical Research and Translational Medicine

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fda

Clinical Research / Pharma News 

FDA Issues Draft Guidance on PBPK Analysis

fda, Guidelines, Recent

US regulatory authority Food and Drug Administration (FDA) on 1st December 2016 released a new draft guidance designed to assist

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Clinical Research / Pharma News 

Erelzi Gets Approval from FDA, a Biosimilar to Enbrel

Enbrel, fda, Sandoz

The US Food and Drug Administration on 30th August accepted Sandoz’s biosimilar to Amgen’s blockbuster Enbrel, which will be identified

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Clinical Research / Pharma News 

Pfizer’s Chantix Not Associated To Serious Psychiatric Side Effects: A Global Study Finds Smoking Cessation Drugs Deemed Safe

Block box warning, fda, Zyban

It is a known fact that in 2009 US FDA kept black box warning for Pfizer’s stop smoking drug Chantix.

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Clinical Research / Pharma News 

FDA Shares Thoughts on Young Animal Studies for Cancer Drugs

fda, ICH, Oncology drugs

According to an article published recently, officers from the US Food and Drug Administration (FDA) say that studies looking at

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Clinical Research / Pharma News 

Halaven Gets Green Light from US FDA to Treat Liposarcoma

Adverse effects, dacarbazine, fda, Liposarcoma

The U.S. Food and Drug Administration has accepted Halaven (Eribulin Mesylate), a kind of chemotherapy, for the therapy of liposarcoma

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Clinical Research and Pharma News 

FDA Stated that Pharmas May Need to Repeat tests as CRO Cetero has Fabricated Trial Data

1 Comment cetero, fda

According to the US FDA, Cetero Research, a North Carolina based CRO, allegedly produced fake clinical trial documents and test

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Clinical Research and Pharma News 

FDA to Employ a Different Process for Approval of Generic Drugs

0 Comments approval, fda, generic

The FDA calls for a shortened approval process for Generic drugs. However, because of the enormously high number of applications

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