Biological products, or “biologics,” are medical products derived from living human, animal, or microorganism sources that are intended to prevent, diagnose, or treat diseases. Today, biologics are on the forefront of medical science and research because they can replicate natural substances in the human body such as enzymes, antibodies, or hormones. Examples of biologics include vaccines, blood and blood components, cellular and gene therapies, and human cells and tissues, including stem cells, used for transplantation or treatment. Biologics are regulated under a complex regulatory framework and require specialized understanding of the laws and regulations that apply to each complex biological mixture.
Fuerst Ittleman David & Joseph understands that introducing a biologic to the world market requires navigating sophisticated and complex laws and regulations, including the Food, Drug, and Cosmetic Act and Public Health Services Act. Our firm helps clients understand the development and application processes and offers essential advice to allow for efficient approval. The attorneys at Fuerst Ittleman David & Joseph are deeply familiar with the wide range of scientific, legal, and regulatory issues that often arise throughout the life cycles of biologics. With this knowledge and expertise, we provide clients with comprehensive strategies for product development, approval, commercialization, and life cycle management that are specifically tailored to each unique product.
Our attorneys work closely with clients to provide in-depth assistance in the earliest development stages to protect innovation and preserve our clients’ positions in the market. In addition to helping clients understand how to comply with the legal and regulatory standards that apply to their biologics, we counsel clients on advantageous approval and marketing strategies, from the investigational stage through expedited approval options such as fast track, accelerated approval, and treatment investigational new drugs. We also assist clients in structuring and negotiating corporate licenses, drafting research and clinical trial contracts, and preparing for FDA inspections or audits.
At the end of the initial product development phase, the firm’s Life Sciences Practice Group assists with drafting and filing Biologics License Applications (BLAs) and Investigational New Drug (IND) applications. Fuerst Ittleman David & Joseph is highly experienced in representing clients through all stages of the application process, including meetings with FDA, internal appeals, administrative proceedings, and enforcement actions and litigation.
We are also well-versed in the manufacturing and marketing requirements applicable to our clients’ unique and cutting edge products. We routinely review proposed labeling, advertising, and promotional materials to ensure compliance with FDA and FTC regulations and policies. Once a product has been introduced to the market, clients turn to us to assist them with adverse event reporting, Field Alert and Biological Product Deviation Reports, and managing product recalls. Our attorneys are experienced in counseling clients through post-market concerns and working with them to develop comprehensive crisis management programs and implement responsive action plans.
Biologics and biotechnology represent the future of medicine. Fuerst Ittleman David & Joseph is here to help you launch your innovative new healthcare solutions and emerging therapies onto the market.