Innovators should develop comprehensive regulatory strategies for conducting scientific and medical testing of innovations to prepare applications, respond and reply to objections, and obtain approval from federal and state agencies to market a life sciences innovation. Attorneys and scientists having experience with regulatory matters governed by the U.S. Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA) and the U.S. Environmental Protection Agency (EPA) are typically engaged to assist with the regulatory process. In addition, attorneys and scientists often work closely with environmental and securities regulatory attorneys when such regulations impact the development of your life sciences technology.
Innovators should also anticipate working with a network of outside consultants and business advisors having expertise in regulatory matters pending before the FDA, USDA, EPA, Drug Enforcement Agency, Federal Trade Commission, Office of the Inspector General of the Department of Health and Human Services, Centers for Medicare and Medicaid Services, Department of Veterans Affairs, Consumer Products Safety Commission, and other federal and state agencies. In combination with this network, innovators should also seek information concerning statutory and regulatory requirements, including product approval and safety issues, current Good Manufacturing Practice (cGMP) requirements, regulatory strategies and life cycle management, labeling, advertising, import/exports (including ITAR and EAR regulations), clinical investigation requirements, product liability, market protections (e.g., Hatch-Waxman exclusivity, orphan drugs, and patent term extensions), and enforcement issues.
Innovators should regularly consult collaboration partners, including contract research organizations (CROs) and contract manufacturing organizations (CMOs), that conduct experimental and analytical work to further develop the technology. By leveraging information and technical data provided by CROs, CMOs, and the innovator's internal efforts, a comprehensive intellectual property strategy can be developed that protects what the innovator predicts will reach the market. In addition, by combining regulatory and intellectual property strategies that leverage collaborative efforts, a business may reach proof of concept, pass investors' due diligence, and begin the pre-clinical trial or drug application process at an earlier stage. All of these aspects of the comprehensive strategy can enhance the value of the life sciences innovation.