Biologics and biotechnology represent the future of medicine. These include monoclonal antibody based drugs, allergenics, vaccines, blood and blood components, genomics and personalized medicine (gene therapy), and human cellular and tissue-based products (HCT/P) including stem cells and xenotransplantation. These products are sophisticated molecules under complex regulation requiring specialized counsel.
The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), is the principal agency involved in the regulation of biologics and biotechnology through the Public Health Service Act (PHSA) and the Federal Food, Drug, and Cosmetic Act (FDCA). Devices are regulated through the Medical Device Amendments of 1976. Animal products are regulated under the Virus, Serum, and Toxin Act, administered by the U.S. Department of Agriculture. A skilled understanding of this multifaceted interplay is required as many of the current regulations are ill-equipped to deal with the rapid advances in science our clients often produce.
Fuerst Ittleman is a pioneering law firm in the field of biotechnology and biologics. We advise clients on the current regulatory framework and guide them through the evolving legislative and policy-based determinants that drive the law. Whether you are an established leader in the industry or a rising business capitalist, Fuerst Ittleman can assist you. Fuerst Ittleman is available through all phases of the research, development, and commercialization process including approval and post-marketing obligations, including but not limited to:
- Establishment Registration and Product Listings
- Inspections
- Advertising and Promotional Labeling Submissions
- General Biological Product Standards
- Current Good Manufacturing Practices (cGMP) And Product Deviations
- Clinical Research and Investigational New Drug Applications (IND)
- Biologic License Applications (BLA) and Supplements
- Postmarketing Surveillance and Other Requirements
- Public Health Threats and Bioterrorism
- Biosimilarity
- Imports and Exports
- FDA Enforcement Actions
- Litigation Involving Biologics and Biotechnology
For more information for how we can assist with Biologics and Biotechnology, please contact us at contact@fuerstlaw.com or (305) 350-5690.
