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
USFDA MD Guidance: Use of RWE to Support Regulatory Decision-Making forMedical Devices
Singapore's HSA: Post-Industry Consultation Updates on eCTD Implementation in Singapore
Philippines FDA: Guidance on Use of FDA eServices Portal for the Initial Application of CMDN
UK MHRA Guidance: Apply for a Parallel Import Licence
UK MHRA: Guidance on Register Medical Devices to Place on the Market