On June 26, 2024, the US Food and Drug Administration (FDA) released its much-anticipated draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies....more
7/16/2024
/ Clinical Trials ,
Comment Period ,
Diversity ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Life Sciences ,
Patient Privacy Rights ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation
On April 15, 2024, the US Food & Drug Administration (FDA) announced the establishment of the Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI). C3TI will serve as the central support...more
In a highly anticipated and scrutinized decision, the Centers for Medicare & Medicaid Services (CMS) released a new public data set on April 30, 2015, that includes detailed data regarding the prescribing patterns of...more
On June 17, 2014, the U.S. Food and Drug Administration (FDA or the Agency) issued two draft guidance documents, providing recommendations for two types of communication over internet and social media platforms. The first...more
On January 22, 2014, the FDA issued finalized guidance on the use, content and form of Dear Health Care Provider (DHCP) letters. While the finalized guidance modifies and removes certain controversial provisions from the...more