Washington, District Of Columbia 20006
is a partner in the Washington, D.C. office of King & Spalding and serves as Deputy Chair of the FDA & Life Sciences Group. Her practice focuses on the regulation of drugs, biologics, and other products by the Food and Drug Administration (FDA), the U.S. Drug Enforcement Administration (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 U.S. Congress, which were considered during the reauthorization of BPCA and PREA (signed into law in July 2012).
|Areas of Practice||1) FDA & Life Sciences , 2) Children’s Health , 3) Health IT and EHRs , 4) Healthcare Industry and 5) Pharma Emerging Companies|
|Law School||J.D., University of Virginia|
|Education||A.B., College of William and Mary|
|Bar Member / Association||State bar of District of Columbia,State bar Virginia|
|Most recent firm||King & Spalding LLP|
Ms. Fitzgerald represents employers in a wide range of industries, including the entertainment, financial services, hospitality, manufacturing, retail, and transportation industries.
Ms. Shander advises public and private company clients as well as private equity funds, with an emphasis on mergers and acquisitions, dispositions, and financing transactions.