Regulatory Blog

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