EMA Guidance: Electronic Submission of Information for Investigational Medicinal Products in XEVMPD
USFDA Guidance: Use of Data Monitoring Committees in Clinical Trials
USFDA CMC Guidance: Advanced Manufacturing Technologies Designation Program
Swissmedic Guidance: Navigating Variations, Product Information, and Electronic ICSRs through PV Gateway
USFDA Guidance: "Understanding the USFDA Notification Process for Discontinuance or Interruption in Manufacturing of Pharmaceutical Products"
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: 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: MAH Submission of Nitrosamine Risk Evaluation, Risk Assessment and Confirmatory Testing
USFDA Guidance: Requests for Reconsideration under GDUFA
EMA: Guidance on Paediatric Submissions & Scientific Guidelines with SmPC Recommendations
UK MHRA: Guidance on 150-Day Assessment for National Applications for Medicines
UK MHRA: Guidance on Operational Information Sharing
USFDA : CMC Guidance Reformulating Drug Products That Contain Carbomers & Potency Assurance for Cellular & Gene Therapy Products
USFDA Guidance: Considerations, Master Protocols for the Development of Drugs and Biological Products
USFDA Guidance: Digital Health Technologies for Remote Data Acquisition & Data Standards for Drug and Biological Product Submissions and Real-World Data