Have questions about FDA 1572s?
FDA has updated its guidance documents for 1572s.
Don't worry, if the FDA 1572 seems confusing, you are not alone. In fact, the FDA updated its Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs--Frequently Asked Questions Statement of Investigator (Form FDA 1572)
The document was posted in July 2008, but according to an Applied Clinical Trials Editorial Advisory Board member believes with the myriad of
activities that clinical operations staff are responsible for some seem to have "missed" this update.
Also, a previous Applied Clinical Trials article on the subject could provide more help.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Merck Launches Phase III Trials of Once-Monthly Oral HIV PrEP Candidate MK-8527
July 14th 2025In the new EXPrESSIVE clinical trial program, Merck will evaluate MK-8527, a once-monthly, oral PrEP therapy, in populations at high risk of HIV-1 infection, including adolescent girls and women in sub-Saharan Africa.
Baxdrostat Shows Significant Blood Pressure Reduction in Phase III BaxHTN Trial
July 14th 2025In the BaxHTN Phase III study, AstraZeneca’s baxdrostat demonstrated statistically significant and clinically meaningful reductions in systolic blood pressure in patients with uncontrolled or treatment-resistant hypertension.
