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.
Since Avalere last discussed Investigational Device Exemptions (IDEs), IDE regulatory and reimbursement policy landscape at FDA and CMS have issued some predicted changes; FDA has issued new draft guidance documents while CMS included many of these changes in their 2013 proposed physician payment rule.
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.
Recent FDA decisions should act as a blueprint for generic and brand manufacturers of innovator products.
To decrease time to market and align data collection efforts, manufacturers must now engage with CMS and FDA more thoughtfully and earlier in the Category B IDE process.