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Regulatory NEWS

A year after receiving a complete response letter (CRL), Eli Lilly and Co. is heading to the FDA Arthritis Advisory Committee Monday to make its case for baricitinib. But as one analyst indicated, it won't be a walk in the park.

High marks for oral anti-epileptic

GW Pharmaceuticals plc CEO Justin Gover said solid science and years of cooperating with not only the FDA but also with the Drug Enforcement Administration (DEA) allowed his firm to reach the brink of an FDA panel meeting on its cannabidiol (CBD) oral solution for types of epilepsy, potentially followed by approval in June.

HONG KONG – The Central Drugs Standard Control Organization (CDSCO) of India is setting up a national database, known as Sugam, of pharmaceutical manufacturers and their medicines to help address drug shortages and quality issues.

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