USFDA Guidance: "Understanding the USFDA Notification Process for Discontinuance or Interruption in Manufacturing of Pharmaceutical Products"
Saudi's SFDA: Good Manufacturing Practice for Blood Establishments
USFDA Guidance: "Understanding FDA's QMSR Final Rule: What You Need to Know for the Transition Period"
USFDA Guidance: Conducting Remote Regulatory Assessments Questions and Answers
WHO Guidance: Ethics and Governance of Artificial Intelligence for Health
MHRA Guidance: MAH Submission of Nitrosamine Risk Evaluation, Risk Assessment and Confirmatory Testing
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
Saudi Arabia’s (SFDA): Requirements for Clinical Trials of Medical Devices
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
UK MHRA: Guidance on Submitting Changes to Labelling and Patient Information Leaflets
Malaysia NPRA: Guidelines for Registration of Biosimilars in Malaysia