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HYDERABAD, India – A number of drug companies in India may have to repeat expensive clinical trials after Bangalore-based CRO Semler Research Center Pvt. Ltd. received warnings from both the WHO and the FDA in April over data manipulation.

A joint bid to deploy Proteus Digital Health Inc.'s ingestible sensor with Tokyo-based Otsuka Pharmaceutical Co. Ltd.'s antipsychotic drug, Abilify, was met with a complete response letter from the FDA.

The FDA's slow pace of developing a U.S. biosimilar path that already trails that of other markets has drawn sharp rebukes from Congress and critics, but the regulator isn't the only force shaping the path.

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