RAPS Reports FDA Notifications to Pharma re: Indian CRO Unacceptability

iStock_000014305021_SmallOn April 20th, 2016, Regulatory Affairs Professionals Society (RAPS) writer, Zachary Brennan, shared insights about recent FDA notifications to sponsors of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) that clinical and bioanalytical studies conducted by Bangalore, India-based contract research organization (CRO) Semler Research are not acceptable as a result of data integrity concerns and need to be repeated. – For the full article visit: http://raps.org/Regulatory-Focus/News/2016/04/20/24802/FDA-to-Pharma-Companies-Indian-CRO%E2%80%99s-Clinical-and-Bioanalytical-Studies-are-Unacceptable/?utm_source=Email&utm_medium=Informz&utm_campaign=RF-Today#sthash.5sm1mXgT.dpuf

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