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FDA Platform Technology Designation Program aims to speed development of drugs, biological products

The U.S. Food and Drug Administration (FDA) has issued draft guidance on its “Platform Technology Designation Program,” which aims to streamline drug development, manufacturing, and marketing application review for products...more

FDA under fire: Pared-down LDT Final Rule leaves unanswered questions

The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate laboratory developed tests (LDTs). Below we summarize the...more

Center for Clinical Trial Innovation furthers FDA’s diversity goals, rare disease drug development - Pilot program offers...

The U.S. Food and Drug Administration (FDA) has announced the establishment of the “Center for Drug Evaluation (CDER) Center for Clinical Trial Innovation” (C3TI). C3TI is intended to be a “central hub” within CDER aimed at...more

FDA advises on RWE non-interventional study use as evidence of effectiveness or safety

Today, the U.S. Food and Drug Administration (FDA) published the draft guidance “Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products,” which provides recommendations to...more

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