Saudi's SFDA: Good Manufacturing Practice for Blood Establishments
Australia TGA: eCTD AU module 1 and regional information
USFDA Guidance: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products
USFDA Guidance: Human Gene Therapy Products Incorporating Human Genome Editing & Development of Chimeric Antigen Receptor (CAR) T Cell Products
USFDA Guidance: Conducting Remote Regulatory Assessments Questions and Answers
USFDA Guidance: Navigating ANDA Submissions Latest Guidance on ANDA Amendments, Requests, and Labeling Revisions
USFDA's ISTAND Pilot Program: Accepts First Submission of AI-Based Digital Tech for Neuroscience
EMA Guidance: Applying for Orphan Designation, IRIS Guide & Orphan Des Procedural Guidance & Forms
WHO Guidance: Ethics and Governance of Artificial Intelligence for Health
MHRA Guidance: Notify the MHRA about a Clinical Investigation for a Medical Device
South Africa's (SAPHRA): Import Applications Of Electronic Devices Emitting Ionizing Radiation
USFDA Guidance: Requests for Reconsideration under GDUFA
EMA: Guidance on Paediatric Submissions & Scientific Guidelines with SmPC Recommendations
USFDA Guidance: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions
UK MHRA: Guidance on 150-Day Assessment for National Applications for Medicines
UK MHRA: Guidance on Operational Information Sharing
India CDSCO: Launching of National Single Window System (NSWS) Portal