People
Chris Markus focuses on U.S. 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 (DEA) 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.
Chris has been recognized by the BTI Consulting Group as a 2017 "Client Service All-Star" and was also named repeatedly as a "Life Sciences Star" by LMG Life Sciences. She continues to be identified as one of The Best Lawyers in America for FDA Law, and ranked as a life sciences practitioner by The Legal 500.
J.D., University of Virginia
A.B., College of William and Mary
District of Columbia
Virginia
The District of Columbia Bar
Virginia State Bar
December 7, 2021
King & Spalding Advises Oaktree Acquisition Corp. II in its Merger with Alvotech
October 5, 2021
LMG Life Sciences Recognizes King & Spalding With Multiple Rankings in its 2021 Guide
April 3, 2021
Creadev invests in Alira Health
Advised multiple pharmaceutical and biological product companies, and investors, on life cycle issues, including patent and market exclusivity eligibility, regulatory strategies, and transactional diligence.
Developed a citizen petition elucidating scientific and legal concerns about FDA's proposed bioequivalence standards.
Performed due diligence for regulatory issues and supported negotiation for corporate licensing, M&A, equity investing and financial institution lending.
See more
April 26, 2022
FDA Proposes Licensing Standards for Drug Wholesalers
February 8, 2022
Europe - Between The EU Clinical Trials Regulation And The UK Guideline On Clinical Trials
November 9, 2021
A Magic Mixing Cauldron for the 21st Century: FDA’s new guidances on using real-world data in regulatory decision-making
December 7, 2021
King & Spalding Advises Oaktree Acquisition Corp. II in its Merger with Alvotech
October 5, 2021
LMG Life Sciences Recognizes King & Spalding With Multiple Rankings in its 2021 Guide
April 3, 2021
Creadev invests in Alira Health
Advised multiple pharmaceutical and biological product companies, and investors, on life cycle issues, including patent and market exclusivity eligibility, regulatory strategies, and transactional diligence.
Developed a citizen petition elucidating scientific and legal concerns about FDA's proposed bioequivalence standards.
Performed due diligence for regulatory issues and supported negotiation for corporate licensing, M&A, equity investing and financial institution lending.
See more
April 26, 2022
FDA Proposes Licensing Standards for Drug Wholesalers
February 8, 2022
Europe - Between The EU Clinical Trials Regulation And The UK Guideline On Clinical Trials
November 9, 2021
A Magic Mixing Cauldron for the 21st Century: FDA’s new guidances on using real-world data in regulatory decision-making
December 7, 2021
King & Spalding Advises Oaktree Acquisition Corp. II in its Merger with Alvotech
October 5, 2021
LMG Life Sciences Recognizes King & Spalding With Multiple Rankings in its 2021 Guide
April 3, 2021
Creadev invests in Alira Health
J.D., University of Virginia
A.B., College of William and Mary
District of Columbia
Virginia
The District of Columbia Bar
Virginia State Bar