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EMA GVP Module VII – Explanatory Note (Rev. 4): Periodic Safety Update Report (PSUR) Single Assessment
The European Medicines Agency (EMA) has issued Revision 4 of the "Explanatory Note to Good Pharmacovigilance Practices (GVP) Module VII – Periodic Safety Update Report" prepared by the Human Medicines Evaluation Division. This revision addresses practical challenges encountered during the PSUR Single Assessment (PSUSA) process, particularly for nationally authorised medicinal products (NAPs), and serves as the basis for the forthcoming update of GVP Module VII. Purpose of the
Sharan Murugan
3 days ago3 min read
USFDA Guidance: Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations
The U.S. Food and Drug Administration (FDA) has issued Revision 1 of its guidance titled "Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations" (May 2026), prepared by the Office of Clinical Pharmacology within the Center for Drug Evaluation and Research (CDER). This revision supersedes part of the 2022 guidance on Food-Effect Bioavailability and Fed Bioequivalence Studies and consolidates current FDA thinking on when, why, and how fo
Sharan Murugan
6 days ago4 min read
USFDA Guidance: Updates on Pain Management, Opioids, Non-Opioid Analgesics, Addiction Treatment, and Tuberculosis Drug Development
The U.S. Food and Drug Administration (FDA) continues to expand its regulatory focus on safer pain management, opioid risk reduction, addiction treatment innovation, and infectious disease drug development through multiple recent guidance documents. These guidances collectively highlight the FDA’s evolving strategy toward: Reducing opioid dependence Encouraging non-opioid therapies Supporting innovative pain treatments Strengthening benefit-risk assessments Advancing addictio
Sharan Murugan
May 173 min read