ICH Generic Drug Harmonization May Be Another Cost-Lowering Opportunity
The international group will work on harmonizing scientific and technical standards for generic drugs, which could reduce duplication and development costs.
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Now that US FDA has approved the final EU authority, mutual recognition efforts could expand and deepen. Former FDA chief counsel Rebecca Wood discusses the future of approval standards harmonization in Pink Sheet interview.
If agency adopts policy, it might obviate the need for the CREATES Act. Biosimilars already enjoy a degree flexibility of on the source of reference material that generic sponsors want extended to the less complicated small molecule drugs.
The latest drug development news and highlights from our US FDA Performance Tracker.