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.
Gilead Shares Final Data from Phase III MYR301 Trial of Bulevirtide in Chronic Hepatitis Delta Virus
May 7th 2025Long-term results from the study show 90% of patients with chronic HDV who achieved undetectable HDV RNA at 96 weeks of treatment remained undetectable for nearly 2 years post-treatment.
