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USFDA Guidance: Participation in Clinical Trials and Study of Sex Differences in the Clinical Evaluation
Clinical trials are the foundation for understanding whether a medical product is safe and effective. However, for many years, clinical trial populations have not fully reflected the patients who ultimately use these products in real-world settings. To address this gap, the U.S. Food and Drug Administration (FDA) has issued two complementary guidance documents: Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs (Decembe
Sharan Murugan
Dec 20, 20253 min read
UK MHRA: Guidance on Good Clinical Practice for Clinical Trials
On 22nd July 2024 the UK Medicines and Healthcare Products Regulatory Agency (MHRA) issued comprehensive guidance on " Good Clinical...
Sharan Murugan
Jul 23, 20242 min read
EC MDCG: Guidance on Clinical Evaluation of Orphan Medical Devices
The European Commission Medical Device Coordination Group (MDCG) has issued a new guidance "Clinical Evaluation of Orphan Medical...
Sharan Murugan
Jun 28, 20242 min read