Regulatory

This designation ensures the highest level of regulatory standards for quality, safety, and efficacy of medicines and vaccines.

The FDA has conducted an investigation and found a combination of factors that may result in potential thermal injuries, particularly when the pad is used with infants and small...

A software issue may cause the app to crash and relaunch, possibly causing under-delivery of insulin.

This collaborative effort comes in the wake of an executive order from President Biden, aiming to ensure public confidence in the biotechnology regulatory system.

The final guidance hopes to address the need for clarity between servicing and remanufacturing for regulatory purposes.