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In-Depth Look at Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs

The FDA will host a meeting on 26 October 2022 to provide additional clarity to the final guidance with respect to Agency expectations for submissions containing Bioavailability information for drug products, and will discuss: Select case studies on various bioavailability (BA) related subtopics (e.g. pharmacodynamic (PD) endpoints, endogenous compound Narrow Therapeutic Index (NTI), biowaivers). Bioavailability

FDA NanoDay Symposium 2022

The FDA NanoDay Symposium 2022 will be held on 11 October 2022. The event will address drug development of products that contain nanomaterials in their formulation and how the newly finalized guidance to industry for products that contain nanomaterials can be implemented in filings to the FDA. Highlighted topic areas include: Primary Chemistry Manufacturing and

Review of Third-Party Research Risk: Is There a Role for IRBs?

"Review of Third-Party Research Risk: Is There a Role for IRBs?," an HHS Office for Human Research Protections (OHRP) Exploratory workshop, will be livecast on 24 September 2021. The research community has generally focused on the protection of human research subjects as defined by the Common Rule. However, sometimes the conduct of research can have