CHRISTINA M. MARKUS is a partner and Deputy Team Leader in the Washington, DC office of King & Spalding for the FDA & Life Sciences Group. Her practice focuses on the regulation of drugs, biologics, and other products by FDA, DEA, and related state agencies (e.g., boards of pharmacy). Ms. Markus represents companies in a range of regulatory compliance, enforcement, and business transactions (e.g., due diligence assessments) involving product development and approval, safety, labeling, marketing and advertising, and supply chain. Ms. Markus was selected as a “Life Sciences Star” in the 2012, 2013, and 2014 LMG Life Sciences publications, and as one of the Best Lawyers in America (2015 edition) for FDA Law. She recently completed an appointment by the Institute of Medicine (IOM)/National Academy of Sciences as the legal member of the IOM Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). In response to a Congressional request, and with funding from FDA, IOM evaluated studies of drugs and biologics that have been performed under two statutory regimes that incentivize and, in some instances, mandate pediatric research through the drug approval process. The Committee assessed historical execution under these laws and offered recommendations and briefings to FDA and the US Congress, which were considered during the reauthorization of BPCA and PREA (signed into law in July 2012).