Tag Archive for: Compliance

The U.S. FDA is cracking down on lax testing practices by dozens of makers of healthcare products following hundreds of deaths overseas from contaminated cough syrups, a Reuters review of regulatory alerts found.

The current resource-intensive approach to PV is facing real challenges as safety data evolves and makes moving to efficient and effective solutions crucial to guaranteeing continued patient safety. Integrating modern technologies, such as artificial intelligence (AI) – which also encompasses machine learning (ML), and natural language processing (NLP) – improves the process, reduces workload for PV professionals, and expedites the gathering and analysis of safety data.

Following reports of destroyed and discarded data, the U.S. regulator issued a warning letter to India’s Intas Pharmaceuticals regarding violations of current good manufacturing practice.

The move comes as Indian regulators step up inspections at drugmakers after cough syrups made in the country were linked to the deaths of dozens of children overseas, denting India’s image as the “pharmacy of the world”.

Med Ad News spoke with Nadia Ward, business development manager at global in vitro diagnostic company bioMérieux, about the company’s role in helping manufacturers produce safe cell and gene therapies.

Remote assessments of an FDA-regulated establishment and/or its records can help determine compliance with applicable FDA requirements, inform regulatory decisions and verify information submitted to the agency, and have been a valuable tool in the nation’s response to the public health emergency.

Adopting digital transformation is now an industry standard for success – but what precisely does that mean for the clinical development landscape? Gary Shorter, Head of Artificial Intelligence at IQVIA, explores the answers.