Julie Tibbets on Sponsors

FDA Issues Overdue Draft Guidance on Clinical Trial Diversity Action Plans

Yesterday, the U.S. Food and Drug Administration (FDA) released its long-awaited draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies....more

6/28/2024 / Clinical Trials , Diversity , Draft Guidance , Food and Drug Administration (FDA) , Medical Research , Sponsors

Common FDA Bioresearch Monitoring Violations: Updates from FY 2022 to Now

The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more

7/12/2023 / Audits , Biotechnology , Clinical Trials , FDA Warning Letters , Food and Drug Administration (FDA) , Inspections , Institutional Review Board (IRB) , Investigational New Drug Application (IND) , Life Sciences , Medical Devices , Medical Research , Pharmaceutical Industry , Sponsors

FDA’s Final Q&A Guidance on Risk-Based Monitoring of Clinical Trials Provides Additional Recommendations for Sponsors

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

4/27/2023 / Clinical Trials , Final Guidance , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs , Risk Assessment , Sponsors

Clinical Trial Diversity Plans and Rare Diseases

Clinical trial diversity is not a new concept–the U.S. Food and Drug Administration (FDA) issued a draft guidance providing specific recommendations to industry on how to improve diversity in clinical trials in April 2022...more

3/23/2023 / Clinical Trials , Diversity , Diversity and Inclusion Standards (D&I) , Food and Drug Administration (FDA) , Life Sciences , Sponsors

Leveraging Investigator-Initiated Trials in Rare Disease Drug Development

Investigators interested in rare disease treatment development have the opportunity to approach drug and biologic developers to obtain investigational drug supply for trials in which the investigators, typically at academic...more

2/23/2023 / Clinical Trials , Colleges , Pharmaceutical Industry , Prescription Drugs , Special Investigators , Sponsors , Universities

Understanding Data Monitoring Committee Conflict of Interest Limitations

For sponsors utilizing a data monitoring committee in their trial designs to monitor for emerging safety signals, lack of effect, and/or futility of treatment, understanding data monitoring committee conflict of interest...more

2/10/2023 / Clinical Trials , Conflicts of Interest , Food and Drug Administration (FDA) , Life Sciences , Special Committees , Sponsors

Common Bioresearch Monitoring Violations: Updates from FY 2021 to Now

The Bioresearch Monitoring Program (BIMO), run by the U.S. Food and Drug Administration (FDA), oversees the conduct of on-site inspections and data audits of FDA-regulated research in support of new product development and...more

6/29/2022 / Audits , Clinical Trials , Compliance , Dietary Supplements , Food and Drug Administration (FDA) , Investigational New Drug Application (IND) , Prescription Drugs , Regulatory Violations , Research and Development , Sponsors , Warning Letters

FDA Answers New Questions on Foreign Trial Sites Operating Under INDs

On May 19, 2021, the U.S. Food and Drug Administration (FDA) released an updated guidance in draft form on how to complete the Statement of Investigator form (Form FDA 1572). The guidance addresses frequently asked questions...more

5/26/2021 / Biologics , Clinical Trials , Food and Drug Administration (FDA) , Guidance Update , Institutional Review Board (IRB) , Investigational New Drug Application (IND) , Pharmaceutical Industry , Sponsors , Waivers

Julie Tibbets

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