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
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and the U.S. Department of Health and Human Services’ (HHS’s) Office for Human Research Protections (OHRP) released a draft guidance titled “Key Information and...more
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 This update follows FDA’s draft guidance, which was issued in July...more
9/6/2023
/ Clinical Trials ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Informed Consent ,
IRB ,
Life Sciences ,
Medical Research ,
New Guidance ,
Pharmaceutical Industry ,
Scientific Research
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(FDA) took additional steps to support the use of decentralized clinical trials (DCTs) by releasing a new draft guidance titled “Decentralized Clinical Trials for Drugs,...more
The Dobbs v. Jackson Women’s Health Organization decision, which effectively removed the federal constitutional protections for abortion, triggered a series of changes for health care providers and patients alike across the...more
On July 1, 2022, the Office for Human Research Protections (OHRP) published a draft guidance document for public comment on the “Use of a Single Institutional Review Board for Cooperative Research” (“Draft Guidance”)....more