Submit Demonstration Program Proposal

by Pill Pals Customer Service | Jun 11, 2025 | News

Content and Format of the C3TI Demonstration Program ProposalThe C3TI Demonstration Program proposal should include the information below and not exceed 10 pages. The sponsor should indicate in their proposal if any items listed below do not pertain to their proposal....

Emergence of Flucytosine-Resistant Candida tropicalis Clade, the Netherlands

by Pill Pals Customer Service | Jun 11, 2025 | News

Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Author affiliation: Radboud University Medical Center, Nijmegen, the Netherlands (F.Z. Delma,...

Demonstration Program

by Pill Pals Customer Service | Jun 11, 2025 | News

The CDER Center for Clinical Trial Innovation (C3TI) Demonstration Program provides an opportunity to test and scale the integration of innovative approaches in clinical trials. The program offers a mechanism for early engagement between CDER and sponsors of clinical...

Promising Effects of Duck Vaccination against Highly Pathogenic Avian Influenza, France 2023–2024

by Pill Pals Customer Service | Jun 11, 2025 | News

Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Author affiliation: Author affiliations: Interactions Hôtes-Agents Pathogènes, Université de...

CDER Employee’s Clinical Trial Experience

by Pill Pals Customer Service | Jun 11, 2025 | News

Strother D. Dixon, a senior regulatory project manager in OND’s Division of Dermatology and Dentistry, received a breast cancer diagnosis on Friday, March 13, 2009. Even with a biology background and pharmaceutical industry experience, she felt overwhelmed with...

Real-World Evidence Submissions to CDER

by Pill Pals Customer Service | Jun 11, 2025 | News

As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA VII), FDA committed to reporting aggregate and anonymized information on submissions to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research...