On June 26, 2024, the U.S. Food and Drug Administration (FDA) issued draft guidance setting forth detailed requirements for the submission of Diversity Action Plans (DAPs) by sponsors of certain clinical studies involving...more
Concerns have grown tremendously in recent years regarding noncompliance in clinical trial reporting. Shockingly, the National Institutes of Health (NIH) failed to disclose the results of over one-third of the clinical trials...more
8/23/2023
/ Clinical Trials ,
Compliance ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Medical Research ,
National Institute of Health (NIH) ,
OIG ,
Pharmaceutical Industry ,
Registration Requirement ,
Reporting Requirements ,
Sponsors
On Aug. 15, the Food and Drug Administration (FDA) issued new guidance aimed at assisting institutional review boards (IRBs), clinical investigators and sponsors in complying with the FDA’s informed consent requirements for...more
In a notable step toward more equitable healthcare, the U.S. Food and Drug Administration (FDA) introduced new draft guidance on August 10, Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical...more
On May 2nd, the FDA published draft guidance regarding the use of DCTs to support the development of drugs, biological products and devices. In contrast to traditional site-based clinical trials, DCTs are characterized by...more
On April 8, the Office for Human Research Protections (OHRP) released guidance on human subject protections matters related to COVID-19. The guidance should be viewed as recommendations rather than binding requirements. The...more
The Food and Drug Administration (FDA) and National Institutes of Health (NIH) have recently finalized or signaled intent to finalize numerous proposals that promise to change the landscape of clinical trial reporting,...more