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FDA Regulatory Pathways

The development of drugs, biologics, and medical devices follows rigorous paths to ensure safe and effective medicines. We create FDA regulatory engagement strategies and help clients interpret FDA regulations, guidance, and the likely impact of legislation. Interpreting FDA priorities, resources, User Fee Acts, and label and promotion requirements, our experts can help you manage your pipeline.

FDA’s Statement on Proposed Hydrocodone Reclassification

On October 24, Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at FDA, issued a statement indicating the Agency's intent to recommend reclassifying hydrocodone combination products from Schedule III to Schedule II products.

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