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FDA Issues Long-Anticipated Draft Guidance on Diversity Action Plans

The Food and Drug Omnibus Reform Act of 2022 (“FDORA” or the “Act”), signed into law on December 29, 2022, required, in part, drug and device manufacturers to submit Diversity Action Plans to the U.S. Food and Drug...more

FDA and OHRP Issue Joint Draft Guidance on Content, Organization, and Presentation of Consent Forms for Research Participants

On March 1, 2024, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services’ (HHS’s) Office for Human Research Protections (OHRP) released a draft guidance titled “Key Information and...more

FDA Issues Final Guidance on Informed Consent for IRBs, Clinical Investigators, and Sponsors

On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July...more

FDA Issues Draft Recommendations for Implementing Decentralized Clinical Trials

On May 2, 2023, the U.S. Food and Drug Administration (FDA) took additional steps to support the use of decentralized clinical trials (DCTs) by releasing a new draft guidance titled “Decentralized Clinical Trials for Drugs,...more

Reminder of March 31 “Right to Try” Reporting Deadline

Pharmaceutical companies that have provided investigational drugs to patients under the Right to Try law should be prepared to comply with the U.S. Food and Drug Administration’s (FDA’s) reporting requirements by March 31,...more

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