The US Food and Drug Administration (FDA) is confronted with significant challenges in its inspection processes due to recent layoffs. Among ...

According to market estimates for 2024 to 2034, demand for regulatory information management systems is likely to register a ...

This blog delves into the rise of rare disease drug approvals and the critical importance of regulatory guidance in shaping ...

One attorney said the ruling “isn’t quite the stake in the heart.” The FDA is unlikely to challenge the court’s decision, but ...

CDSCO directs States to halt sale of unapproved FDC drugs, emphasizing safety and compliance with drug regulations.

ensuring compliance with regulatory standards. She stated that only shops that meet the conditions will be allowed to resume ...

aims to strengthen regulatory knowledge and facilitate the exchange of best practices. In collaboration with the Central Drugs Standard Control Organisation (CDSCO), the NIHFW has developed ...

They have also been asked to review their approval process for such fixed dose combination drugs (FDC) and ensure strict ...