Both established brands and innovative startups turn to Alston & Bird’s FDA attorneys for counsel on various FDA regulatory and compliance matters affecting prescription and OTC drugs, biologics, medical devices, in vitro diagnostics, food ingredients, supplements, cosmetics, and tobacco products. Our experience includes highly visible litigation, as well as discreet resolution of potentially serious charges. We have extensive experience with issues occurring throughout the product life cycle, including those related to clinical trials, product applications, market entry, product promotion, current good manufacturing practices (CGMPs), quality system regulations (QSRs), and product recalls. We also provide regulatory advice and FDA due diligence support for corporate financing and mergers and acquisitions. On legislative matters, we assist in the development of policy and implementation strategies, help draft legislation and testimony, prepare clients for interviews with congressional committee staff, assist with agency oversight, and provide advice on pending legislation.
Clients in the food, drug, device, cosmetic, supplement, and tobacco industries come to us for creative and business-minded solutions to the regulatory challenges they face. Our technical prowess and comprehensive understanding of the industry and regulatory bodies—where our lawyers have actually served—coupled with our responsiveness, effectiveness, and seamless access to practitioners in other legal areas affecting food, drug, device, and other industry clients regulated by FDA, CMS, HHS, FTC, TTB, USDA, and other federal and state government agencies sets our team well ahead of the competition.
We have been recognized by the American Health Lawyers Association, Chambers USA, and other ranking organizations as one of the nation’s top health care law firms. We are also recognized in The Best Lawyers in America in both biotechnology and health care and by U.S. News-Best Lawyers® “Best Law Firms” in FDA Law.
FDA/Food, Drug & Device
FDA regulatory, compliance, and litigation matters require experienced counsel who regularly interact with the FDA. We analyze risks, help maintain compliance, handle crisis management, and litigate throughout the life cycle of FDA-regulated products and services. We spot opportunities and help lower legal/regulatory hurdles so you can focus on the important commercial needs of your business.
Phone: +1 202 239 3648
Phone: +1 202 239 3465