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Susan Haigney is lead editor of BioPharm International®.
April 11, 2024
The draft guidance provides recommendations for data integrity for clinical and bioanalytical portions of bioavailability and bioequivalence studies submitted with drug applications.
April 04, 2024
The annual report details OPQ’s quality assurance work for 2023 including its support for the creation of guidance documents.
March 30, 2024
The company is voluntarily recalling the product for potential super potent bottles due to overfilling.
March 29, 2024
Dr. Reddy’s has gained exclusive rights to promote and distribute Sanofi’s vaccines in India.
March 22, 2024
The company is recalling one lot of the product because of the potential presence of silicone particulates.
March 15, 2024
The draft guidance document provides support to sponsors with drugs in clinical development that treat the states of sporadic Alzheimer’s disease.