US FDA Publication on Integrating Artificial Intelligence into Healthcare Product
On March 2024, the FDA released its latest publication titled “Collaborative Efforts: Harnessing Artificial Intelligence in Medical Products,” shedding light on the concerted actions undertaken by CBER, CDER, CDRH, and OCP in navigating the landscape of AI integration within the medical product realm. This comprehensive document delineates strategic focal points essential for advancing the application of AI throughout the entire lifecycle of medical products.
The US FDA Updates Meeting Procedure for under PDUFA VII and BsUFA III
Starting February 2023, The US FDA Updates Meeting Procedure for under PDUFA VII and BsUFA III
THE US-FDA Urges Drug Manufacturers to Develop Risk Management Plans to Promote a Stronger, Resilient Drug Supply Chain
FDA published FDA Urges Drug Manufacturers to Develop Risk Management Plans to Promote a Stronger, Resilient Drug Supply Chain.
THE US-FDA publishes product-specific guidances (PSGs) to facilitate generic drug development
On May 2022, the FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug application (ANDA) approval, helping to streamline generic product