The US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.

The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to ...

Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...

Exo-Top was established under the jurisdiction of the State of Nevada. Basing Exo-Top in the U.S. offers key advantages, including proximity to strategic partners, access to a robust biopharma ...

The industry is grappling with significant market shifts amidst emerging technologies and changing demands. Companies are now ...

Life sciences trends 2025 include the rise of personalized therapies, supply chain resilience, compliance, and collaboration ...

The ISO 13485 standard is essential for ensuring the safety and effectiveness of medical devices and aligns with the recent U.S. FDA Quality Management System Regulation that harmonizes U.S. and ...

In today’s fast-paced world, maintaining optimal digestive health can often feel like a daunting task. With so many products ...

In the pursuit of weight loss, individuals often find themselves overwhelmed by countless products and methods that promise ...

ticagrelor – a major unmet medical need in heart attack patients requiring surgerySuccessful MDSAP certification confirms compliance with Health Canada and U.S. FDA quality management system ...

The Louisiana Legislative Auditor's Fiscal Review Committee has voted to place the city of Bogalusa under fiscal administration, citing severe financial distress.

During drug development, AI has been used to ... regulatory compliance include the implementation of a strong quality management system (QMS), proactive audits and inspections, regular training ...