Christina M. Markus focuses on federal and state regulation of drugs, biologics, biotechnology and related products. As a partner in our FDA and Life Sciences practice and Deputy Practice Group Leader, Chris represents clients in a range of regulatory strategy and compliance evaluations, enforcement matters, and business transactions.
Chris represents drug, biologic and other healthcare products companies and investors with compliance and enforcement under the Food and Drug Administration, the Drug Enforcement Administration and related state agencies such as boards of pharmacy.
She also represents clients in business transactions, including strategic planning, due diligence and assessment, that involve product development and approval, safety, labeling, marketing and advertising, manufacturing and supply chain.
Based on her experience, Chris was chosen to serve as the legal member of the Institute of Medicine’s Committee on Pediatric Studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. IOM evaluated studies of drugs and biologics performed under two statutory regimes that provide incentives and, in some instances, mandate pediatric research through the drug approval process.
The Committee assessed the findings and offered recommendations and briefings to FDA and the U.S. Congress. Committee findings and recommendations were considered during the reauthorization of BPCA and PREA in July of 2012.