USFDA Guidance: Finalized REMS Format, Content and Technical Conformance Guide
EMA Guidance: Procedural Advice for Orphan Medicinal Product Designation
EMA Guidance: Anonymisation of PPD & CCI - Preparation of Risk Management Plans (RMP)
USFDA Guidance: Expanded Access to IND Q&A and Assessing User Fees under OMUFA
USFDA Guidance: Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
UK MHRA: 150-Day Assessment for National Applications
SFDA Guidance: Good Regulatory Practice & National Diagnostic Reference Levels
UK MHRA Guidance: Register to Manufacture, Import or Distribute Act.Sub, & Reclassify Products
USFDA Guidance: Multiple Guidances related to Oncology
USFDA Guidance: ANDA Submissions – Prior Approval Supplements - Under GDUFA
EMA Guidance: Scientific Advice and Protocol Assistance
UK's MHRA Guidance: Software & AI as a Medical Device Change Programme
UK MHRA Guidance: How to get a Parallel Import Licence in UK
EMA Guidance: How to Fill the Application Form for Centralised Type IA and IB Variations
MHRA Guidance: Export Drugs & Medicine, Active substances Manufactured in GB for use in EEA & NI
Japan PMDA: Guidelines for Labeling of Codes on Containers to Identify Prescription Drugs & Med. Dev
Philippines FDA: Guidelines on the Unified Licensing Requirements
USFDA MD Guidance: Postmarket Surveillance & Procedures for Handling Post-Approval Studies
Artificial Intelligence in Regulatory Affairs