It is the common goal of product developers and manufacturers, entrepreneurs, financiers and other investors to seek new development opportunities in the constantly evolving field of medical health and technology. But each faces different challenges once an opportunity is discovered. Our attorneys advise and represent drug, biological and medical device companies in all phases of the product development lifecycle. Using a cross-discipline approach, we assist our clients in meeting all regulatory requirements for the approval or clearance of medical products. At the same time, we advise our clients on financing of new development opportunities, strategies and plans to protect their products from unfair competition in the post-approval marketing period, and to ensure proper payments for approved products by third-party payors such as insurance companies, Medicare and Medicaid.

We provide advice on the bench, pharmacogenomic, preclinical, animal and clinical testing, clinical trial and marketing application requirements to support approval or clearance of drug, biological, medical device and combination (drug-device-biologic) products. We help our clients navigate the myriad regulatory requirements, and we advise our clients on the most appropriate regulatory pathway for each product. We facilitate meetings between our clients and all appropriate FDA review officials prior to and during the investigational, application submission and review stages. Our attorneys work with the FDA to promptly address and resolve any concerns the agency may have about a submission, or a pre-approval inspection, that could delay product approval or clearance.

To meet these development and marketing challenges, we work with our clients to prepare and submit:

• NDAs and ANDAs
• BLAs and HCT/P registration and listing
• PMAs and 510(k) notifications
• NADAs and ANADAs
• INDs and IDEs
• Combination product requests for designation (RFDs)
• Product jurisdiction determinations
• Citizen petitions
• Appeals of agency action
• Food additive GRAS opinions and petitions
• PDUFA and MDUFMA user fee waivers
• Pan-European drug, biological product and medical device approvals and clearances
• Requests for administrative hearings
• Comments to FDA administrative proceedings
• Comments on guidance documents and proposed legislation