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FDA Questioned Merck for Failure to Conduct Animal Study

FDA Questioned Merck for Failure to Conduct Animal Study

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Published by januvialawyers
The FDA has clearly elaborated in the warning letter about the neglect of the company to present a final protocol for the three-month rodent study in accordance to what has been agreed upon. The FDA also revealed that Merck failed to provide a justified reason why they missed the deadline. Read more here: januvialawyers.net
The FDA has clearly elaborated in the warning letter about the neglect of the company to present a final protocol for the three-month rodent study in accordance to what has been agreed upon. The FDA also revealed that Merck failed to provide a justified reason why they missed the deadline. Read more here: januvialawyers.net

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Categories:Types, Research
Published by: januvialawyers on Jul 01, 2013
Copyright:Attribution Non-commercial

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07/01/2013

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FDAQuestionedMerckforFailuretoConductAnimalStudy
Merck & Co, a known giant drug manufacturer, has been put to task by the US Food and DrugAdministration foritsinability tocommittofollow theproperregulationswhenitfailedtoengageinan animal study of pancreatitis risk that is brought about by their diabetes drug, Januvia, onlinesource report. A warning letter has been publishedonFebruary 17by theagency toMerck&Co.forfailure to comply with the approved timetableandfailedtoshow goodcausefornotconductingtheadditional testing required to evaluate possible association of Januvia and risks of pancreatitisaccording to a news article from medpagetoday.com. Januvia is an oral pill made by Merck&Co.totreat adult patients with type 2 diabetes, but its efficiency has been questioned due to reports of adverseJanuviasideeffectssuchasrisksofdevelopingpancreatitisleadingtopancreaticcancer.The FDA has clearly elaborated in the warning letter about the neglect of the company topresentafinal protocol for the three-month rodent study in accordance to what has been agreed upon. TheFDA also revealed that Merck failed to provide a justifiedreasonwhy they missedthedeadline.Theinitial agreement required the company to conduct an evaluation by administering a three-monthstudy on pancreatitis risk in a diabetic rodent. Thus the agency reiterates thatfailuretocomply isaviolation concerning public health because the purpose for this study is to further assess a signalseriousriskofacutepancreatitisassociatedwiththeuseofJanuvia.The purpose for this requirement is to figure the series of reports that point out the association of Januviaandtheriskofdevelopingadversemedicalconditions,suchasacutepancreatitis.Merck, on the other hand, responded through a written statement asserting that the company willsubmit a final protocol for the required study to the Food and Drug Administration for reviewwithin thirty days and will start the study within six months and would revise its proposal asnecessary toachievetheagency’sagreement.Hence,anassurancewasgivenby thecompany tofullyobligeinhavingallthenecessaryrequiredcompletedandisbeentakingthematterveryseriously.

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