The Food and Drug Administration's Oversight of Clinical Trials
The Food and Drug Administration's Oversight of Clinical Trials
WASHINGTON, DC, September 28, 2007-The Office of Inspector General (OIG) received a congressional request to review FDA oversight of clinical trials after a series of news articles highlighted vulnerabilities. The OIG aimed to determine the extent to which the Food and Drug Administration (FDA) conducted inspections of clinical trials from fiscal year (FY) 2000 to FY 2005, and to assess FDA’s processes for inspecting clinical trials. They found that data limitations and other factors inhibit FDA’s ability to effectively manage the bioresearch monitoring (BiMo program), and that the FDA inspected approximately 1 % of clinical trial sites during the fiscal year 2000–2005 period.
To read the full report, please click on the link below.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
FDA Grants Ziftomenib with Breakthrough Therapy Designation for NPM1-Mutant Acute Myeloid Leukemia
April 23rd 2024Data from the Phase Ib portion of the KOMET-001 trial showed that the once-daily oral treatment may provide a substantial improvement over available therapies for relapsed/refractory NPM1-mutant acute myeloid leukemia.
