Reagan-Udall Foundation for FDA Launches Navigator Website
Reagan-Udall Foundation, the non-profit foundation for the FDA, launched a new website called Expanded Access Navigator. It features a pharma company directory of expanded access policies and criteria, along with educational resources, guides, and downloadable forms.
The American Cancer Society, the American Society of Clinical Oncology, the Biotechnology Industry Association, FDA, Foundation Medicine, PhRMA and Susan G. Komen helped develop the Navigator along with the support of Bristol-Meyers Squibb, Genentech, Janssen, Lilly, Merck and Pfizer.
Read the full release here.
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.
First Patient Dosed in Phase III Trial of Enhertu as First-Line Treatment for Endometrial Cancer
June 10th 2025In combination with rilvegostomig or Keytruda, Enhertu will be evaluated versus chemotherapy in the DESTINY-Endometrial01 study for the treatment of patients with HER2-expressing, mismatch repair proficient primary advanced or recurrent endometrial cancer.
