Clinical Trial Best Management Informative

The U.S. Food and Drug Administration today announced another major step in its initiative to streamline the development of biosimilar medicines, which are like “generic” versions of biologic drugs...

Today, FDA published the new draft guidance for industry, “New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers.” This guidance is intended to assist...

Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence StudiesSponsor Responsibilities — Safety Reporting Requirements and Safety ...

Expanded Access to Investigational Drugs for Treatment Use: Questions and AnswersOctober 2025 Final Level 1 Revised GuidanceSearch for FDA Guidance DocumentsCross-cutting Guidance DocumentsSearch G...

Conducting Clinical Trials With Decentralized ElementsSeptember 2024Final Level 1 GuidanceSearch for FDA Guidance DocumentsSearch General and Cross-Cutting Topics Guidance DocumentsAdvisory Committ...

The purpose of this guidance is to provide recommendations to sponsors on the assessment of overall survival in randomized oncology clinical trials conducted to support marketing approval of drugs ...

Myelodysplastic Syndromes: Developing Drug and Biological Products for TreatmentDraft Guidance for IndustryJuly 2025 DraftNot for implementation. Contains non-binding recommendations.This guidance ...

For Immediate Release:April 10, 2025Today, the U.S. Food and Drug Administration is taking a groundbreaking step to advance public health by replacing animal testing in the development of monoclona...