Podcast: Unpacking FDA's Final Clinical Decision Support Guidance - Diagnosing Health Care
Wiley Webinar: Biotech Briefings – Interim Update on Regulatory Developments Relevant to Plant Biostimulants
Edible Bites Episode 2: Cannabis and Life Sciences Video Webinar Series
The U.S. Food and Drug Administration (FDA or the Agency) has issued the final guidance document, “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” (Final Guidance). The...more
The U.S. Food and Drug Administration (FDA) recently finalized its guidance, “A Risk-Based Approach to Monitoring of Clinical Investigations” (the “2023 RBM Guidance”) which follows up on the Agency’s March 2019 draft...more
FDA’s recent release of new guidance on civil money penalties for the failure to submit required information to the ClinicalTrials.gov data bank may indicate a renewed interest in the enforcement of these requirements. On...more