FDA’s latest guidance available – General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products; Draft Guidance for Industry

On December 08, 2014, US Food and Drugs Administration (FDA) issued draft guidance for industry entitled “General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products.” This guidance provides recommendations to sponsors on how to Continue reading

The FDA Releases New Guidance Document to Strengthen Cybersecurity of Medical Devices

The US FDA has released a final guidance document Content of Premarket Submissions for Management of Cybersecurity in Medical Devices to strengthen the safety of medical devices.

Although medical devices have the ability to improve patient care and create efficiencies in the healthcare system as they become more interconnected and interoperable, risks for Continue reading