KKB handles legal and regulatory issues associated with prescription drugs and biologics, as well as OTC drugs - including development, FDA approval, and marketing. Our focus is on strategic planning to minimize regulatory problems and maximize the availability of safe and effective products. We routinely negotiate with FDA on legal and policy issues, and engage in litigation relating to FDA regulation and enforcement.
KKB assists clients in developing and implementing healthcare compliance programs in accordance with the OIG Compliance Program Guidance for Pharmaceutical Manufacturers, the PhRMA Code on Interactions with Healthcare Professionals, the AdvaMed Code of Ethics on Interactions with Health Care Professionals, and related state laws, such as California's S.B. 1765 (2004). KKB drafts key documents for clients, including detailed policies and procedures, needed to support a client's compliance program and will conduct training of affected employees. KKB monitors enforcement trends and helps clients keep compliance programs up to date.