Can we help?
Providing a current and concise introduction to U.S. Food and Drug Administration (FDA) and related federal regulation of medical devices, drugs, and biological products derived from biotechnology, this concise new guide assists attorneys who need to understand the often complicated infrastructure that governs their clients in the biotechnology industry.
Based on the understanding that nearly every legal issue related to biotech clients is ultimately informed or influenced by this governing legal framework, Medical Biotechnology: Premarket and Postmarket Regulation helps lawyers in all areas, whether prosecuting biotechnology patents, negotiating IP licenses, handling corporate M&As, handling product liability issues, to name just a few.
With significant experience counseling clients on a wide range of biotechnology issues, the book’s authors have either worked at the FDA or have been nationally recognized for their expertise in biotechnology law, or both. Clearly written and thorough, the book’s chapters also include valuable information for practitioners, including practice tips, acronym lists for each chapter, and extensive footnotes.
Four chapters address key issues in this regulatory framework: