DISCOVERY
Uncover breakthrough
innovations during the drug
discovery phase.
innovations during the drug
discovery phase.
Early Collaboration with FDA for Novel Programs: Maximizing the Emerging Technology Program (ETP)
Established in 2014, the U.S. Food and Drug Administration’s (FDA) Emerging Technology ...
FDA Issues Final Guidance About Multiple Endpoints in Clinical Trials
On October 21, 2022, the U.S. Food and Drug Administration (FDA) issued the “Multiple ...
Aligning Your Clinical Operating Model – a Case Study by CSL Behring
CONTENT IN COLLABORATION WITH CSL BEHRING Valerie Reynaert, Head of Global Clinical ...
FDORA and the Diversity Action Plan Requirement – Are You Prepared?
The U.S. Congress recently took action to improve diversity in clinical trials by ...
Critical Considerations to Advance Gene Therapy Products for Rare Diseases
The U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research ...
Future Proofing Your Clinical Data Infrastructure
Content in Collaboration with eClinical Solutions Written by: Raj Indupuri, CEO, ...
The Role of Clinical Research: Patient Trust through Trusted Science
The American public often consumes news quickly through online sources, and the feeds of ...
New Year, New Accelerated Approval
When sponsor companies (i.e., applicants) are granted Accelerated Approval (AA) by the ...
Executing in a Year of Correction: Doing More with Less
As we begin a new year, a singular message rings true across all pockets of the life ...
Behind the 2022 CDER Decline in Marketing Application Approvals
As biopharma companies move into 2023 with a focus on product development, establishing ...