Regulatory Strategy and FDA Policy

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 Releases Final Guidance on Pre-Submission Program for Medical Devices

On Feb. 18, FDA released guidance outlining how an applicant can obtain FDA feedback on a potential or planned medical device submission reviewed by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER), including the Pre-Submission (formerly pre-Investigational Device Exemption (pre-IDE)) program.

Brenda Huneycutt to Moderate FDA Panel at the 2014 Biotech Showcase in San Francisco

Join Avalere's Brenda Huneycutt, FDA Policy & Regulatory Strategy Practice, who will be moderating a panel with Avalere's Jenny Gaffney and other leading experts at the Biotech Showcase in San Francisco on Tuesday, January 14th at 8am, titled "FDA: where it's going and how it affects biotech."

Centralized Review of Investigational Device Exemptions at CMS-An IDEa Whose Time Has Come

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IDE regulatory and reimbursement policy landscape at FDA and CMS have issued some predicted changes; FDA has issued new draft guidance documents while CMS included many of these changes in their 2013 proposed physician payment rule.

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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