On December 1, 2020, Womble Bond Dickinson attorneys Sara Tucker and Dan Orr, along with Regulatory Scientist Heather Hatcher, Ph.D., engaged in a panel discussion for SCBIO on “How to Navigate the FDA Approval Process and Other Regulatory Issues”. Moderated by Womble Bond Dickinson attorney Stephanie Few, the panelists discussed recent issues they’ve faced regarding FDA approvals and how early stage companies can fast track their products to market.
The panel also touched on FDA issues regarding COVID-19. They discussed the long term safety of the vaccine, reliability of differently manufactured face masks, and how several companies have shifted their focus to help communities stay safe.
Stephanie Few works with new and expanding businesses in identifying and negotiating all aspects of a complete incentive package, advocating before the proper entities during all phases of the incentive approval process and drafting all related documentation for Fee-in-Lieu of Tax Agreements, state grants, job tax credits, job development credits, utility grants and many other economic development incentives and grants.
Sara Tucker concentrates her practice on complex products liability litigation with a focus on pharmaceutical and medical device litigation. A veteran trial lawyer, Sara has experience defending clients in high-stakes mass tort and multi-district cases in federal and state courts
Dan Orr guides clients in regulatory and policy issues in the pharmaceutical and biotech sectors, such as exclusivity for drugs and biological products, life-cycle management, product classification and jurisdiction, and FDA dispute resolution.
Heather Hatcher, Ph.D. helps clients prepare responses to the FDA and provides regulatory advice on best practices for Phase I/Phase II clinical trials, standard operating procedures and protocols for Good Manufacturing Practices (GMP), and quality control testing for stem cell therapy and biomaterials.