Biotechnology, Pharmaceutical, and Medical Device Compliance
Within the Department of Health and Human Services, the Food and Drug Administration is the U.S. regulatory body relative to the development and use of therapeutic biological products, drugs, and medical devices. Manufactures and sellers of products used for the treatment, prevention, or cure of disease in humans must register with the FDA and pay an annual fee. Registered organizations are subject to FDA inspection, and Hibbs Law, LLC can assist you in appropriately responding to F483 results, untitled letters, and warning letters. Additionally, each therapeutic biological product, drug, or medical device must be approved for use in both human clinical trials and then to the public at large; or be considered otherwise comparably equivalent to such products that have already been shown to have the requisite safety and efficacy. Hibbs Law, LLC is ready to help you with your 510(k), Pre-market Approval, Biologic License Application, New Drug Application, Investigational New Drug Application, and Abbreviated New Drug Application submissions.
Before a chemical or compound becomes a medical treatment, early-stage research must identify the relevant biological targets and develop known pharmacological activity or other identifiable activity. This process to develop a potential therapeutic medicine or product is a daunting endeavor that requires commitment, investing of time and money, and unrelenting focus. It is possible that methods and techniques you need for your research are already subject to patents owned by entities that may seek to prevent our use. In some cases you research may qualify under the Hatch-Waxman §271e(1) as safe harbor. Hibbs Law, LLC can help evaluate your practices to lower risk. Knowledge of good practices and guidelines from the beginning will put a research team on the right track to pursue potential medicines and devices.
Clinical testing and public use/sale of FDA regulated products also generate issues of Quality Systems Regulations (QSR) and current Good Manufacturing Practices (cGMP). Even labeling and marketing is regulated. Hibbs Law, LLC can assist you in reducing non-compliance risk. Therapeutic biological products also face additional requirements of safety, purity, and potency under the Public Health Services Act, when applicable to the prevention, treatment, or cure of a disease or condition of human beings. Therapeutic biological products includes: viruses, therapeutic serums, toxins and antitoxins, vaccines, blood and blood component derivatives, proteins, immunomodulators, and monoclonal antibodies.
Hibbs Law, LLC is looking to form long-term relationships with research teams, diagnostic groups, start-up biotechnology entities, generic developers/manufactures and other health care innovators in pursuing their dream to improve quality of life for human kind.