Include more govt sites for Phase III clinical trial of Ursodeoxycholic Acid Tablets: CDSCO panel to Abbott

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The Subject Expert Committee (SEC) in its 35^th meeting held on 17.02.2021 at CDSCO HQ New Delhi reviewed the Gastroenterology and Hepatology related proposals. After detailed deliberation the committee recommended to revise the Phase III clinical trial as below:

1. Obstetric ultrasound to be performed for evaluation of foetal growth retardation at the time of enrolment.

2. Patients with Hepatitis A & E infection and foetal growth retardation should be excluded from the study.

3. Dose of the study drug should be clearly defined in the protocol along with criteria for dose titration.

4. More Government sites are to be included.

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Accordingly, the CDSCO panel directed the firm Abbott to submit the revised protocol for review by the committee.

Abbott Laboratories is a global healthcare leader having its roots in America. It has its headquarters in Abbott Park, Illinois, The United States. The company started its journey back in 1888 to formulate known drugs. In the present times, the company is involved in the manufacturing and marketing of medical devices, diagnostics, branded generic medicines, and nutritional products.

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