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Drug applications based on Semlers data unacceptable: USFDA

Drug applications based on Semlers data unacceptable: USFDA

New Delhi : Coming down hard on Semler Research Center over data integrity issues, USFDA has told drug firms that their applications seeking approvals on the basis of studies done by the Bangalore-based firm will not be accepted.

Instead, USFDA said, the firms will need to furnish clinical research by other approved entities.

“FDA is notifying sponsors of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) that clinical and bioanalytical studies conducted by Semler Research Private Ltd are not acceptable as a result of data integrity concerns, and need to be repeated,” the United States Food and Drug Administration (USFDA) said in a notification.

The letter informs the sponsor that it must repeat the bioequivalence/bioavailability studies using an entity other than Semler at an acceptable alternate study site, it added.

Semler is a contract research organisation that conducts bioequivalence and bioavailability studies for a number of pharmaceutical companies.

The action is being taken as a result of an inspection of Semler’s bioanalytical facility in Bangalore conducted between September 29, 2015, and October 9, 2015, USFDA said.

It added that the inspection found significant instances of misconduct and violations of federal regulations, including the substitution and manipulation of study subject samples.

The regulator has also written letters informing the sponsors whose applications that are currently under review that include data from studies conducted at Semler.

The latest development is somewhat similar to the European Union ban in July 2015 on the marketing of around 700 generic medicines for alleged manipulation of clinical trials conducted by GVK Biosciences.

The decision taken was in response to a recommendation by the EU drug regulator European Medicines Agency (EMA) in January that marketing authorisation of these drugs should be suspended as they were based on clinical trial data allegedly manipulated by the Hyderabad-based company.

Source: PTI
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