Podcast - Credit Funds: How PE Funds Can Address and Minimize Conflict When Expanding Into Credit
The U.S. Food and Drug Administration (FDA) on Sept. 20, 2025, issued draft guidance, "Expedited Programs for Regenerative Medicine Therapies for Serious Conditions," outlining how sponsors can utilize FDA's expedited review...more
Key Takeaways: The draft guidance represents the first-ever specific expectation by FDA that sponsors develop a diversity plan for trials. FDA’s recommendations come as part of increasing interest in ensuring clinical...more
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