SAHPRA's: Guidelines for Medical Device Adverse Event Reporting
TGA: Australian Regulatory Guidelines for Medical Devices (ARGMD)
USFDA Guidance: Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH)
UK MHRA Guidance: Applying for a Licence to Market a Medicine in the UK
USFDA: CDER Establishes New Center for Real-World Evidence Innovation (CCRI)
USFDA Guidance: Standardized Format for Electronic Submission of NDA and BLA Content for Bioresearch Monitoring (BIMO) Inspections
USFDA Draft Guidance: Accelerated Approval – Expedited Program for Serious Conditions
USFDA Final Guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
USFDA Guidance: Enhancing Communication and Guidance Development Practices
UK Med Dev Guidance: Clinical Investigations for Medical Devices
UK MHRA Press Release Trials Innovative AI Technologies in Regulatory Pilot Scheme