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New FDA Draft Guidance Aims to Eliminate Labeling Headaches for Drug Developers Submitting a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) is

How to Centralize Credential Verification for Local HCPs in Decentralized Clinical Trials (DCTs) In a recent article, Dan Schnell, Chief Editor at Clinical Leader, talked

On January 6, 2025, the FDA issued draft guidance titled Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological

Clinical trials have become increasingly complex over the last few years. More data is available than ever, trial designs are more intricate, and there’s an

National Institutes of Health Develops New Algorithm to Accelerate Clinical Trial Enrollment and Research Volunteer recruitment is one of the biggest challenges biopharmas face. Even

Patient-Centric Trials: How Using Technology Can Enhance the Participant Experience Traditionally, clinical trials emphasized scientific data collection and adherence to strict regulatory requirements. This focus