- Dec 30, 2023
- 1 min
Saudi Arabia’s (SFDA): Requirements for Clinical Trials of Medical Devices
- Dec 30, 2023
- 2 min
USFDA : CMC Guidance Reformulating Drug Products That Contain Carbomers & Potency Assurance for Cellular & Gene Therapy Products
- Dec 27, 2023
- 2 min
USFDA Guidance: Considerations, Master Protocols for the Development of Drugs and Biological Products
- Dec 27, 2023
- 2 min
USFDA Guidance: Digital Health Technologies for Remote Data Acquisition & Data Standards for Drug and Biological Product Submissions and Real-World Data
- Dec 27, 2023
- 2 min
UK MHRA: Guidance on Submitting Changes to Labelling and Patient Information Leaflets
- Dec 19, 2023
- 1 min
Malaysia NPRA: Guidelines for Registration of Biosimilars in Malaysia
- Dec 19, 2023
- 2 min
USFDA MD Guidance: Use of RWE to Support Regulatory Decision-Making forMedical Devices
- Dec 11, 2023
- 1 min
Singapore's HSA: Post-Industry Consultation Updates on eCTD Implementation in Singapore
- Dec 6, 2023
- 2 min
Philippines FDA: Guidance on Use of FDA eServices Portal for the Initial Application of CMDN
- Dec 5, 2023
- 2 min
UK MHRA Guidance: Apply for a Parallel Import Licence
- Dec 3, 2023
- 1 min
UK MHRA: Guidance on Register Medical Devices to Place on the Market