BACKGROUND
FOCUS AREAS
AWARDS & HONORS
More than 15 years of food and drug legal, policy, and regulatory experience at the FDA, on Capitol Hill, and in the private sector.
Regulatory policy
Regulatory compliance and enforcement
Expert witness and litigation support
FDA CDER Center Director’s Special Citation for Compounding Policy Development
FDA Commissioner’s Special Citation for FDA Zika Virus Response Team
FDA Group Recognition Award for Unapproved Drug Seizure Group
Kalah continues her commitment to public health at ELIQUENT Life Sciences by providing strategic counsel to clients on compliance, enforcement, and policy matters. Kalah counsel’s clients across a range of product sectors and is knowledgeable about multiple areas of FDA regulation, including drugs and biologics, compounding, unapproved drugs, diagnostics, digital health, cosmetics, and cell and gene therapy.
Kalah leverages her experience at FDA, on Capitol Hill and in the private sector to advise clients on regulatory policy, compliance, enforcement, and other actions. Before joining Eliquent, Kalah spent six years at the FDA, including as Deputy Chief of Staff to Commissioner Robert Califf. As Deputy Chief of Staff, Kalah worked with senior FDA leadership to manage crises, develop policy decisions, implement communications strategies, and liaise with the Department of Health and Human Services, the White House, and other agencies. Kalah was also a primary point of contact in the immediate Office of the Commissioner for the six FDA Centers and other components of the Commissioner’s Office.
Prior to that role, Kalah spent time on Capitol Hill as the FDA detailee to the Senate Committee on Health, Education, Labor, and Pensions, working on the 21st Century Cures Act and other FDA-related legislation. She has also served in the FDA’s Center for Drug Evaluation and Research (CDER) as a regulatory counsel in the Office of Regulatory Policy, and as Director of CDER’s Office of Unapproved Drugs and Labeling Compliance in the Office of Compliance, leading a team of more than 50 staff working on pharmacy compounding, unapproved drugs, over-the-counter drugs, and other enforcement issues.
Before joining the FDA, Kalah was an associate at the law firm Foley Hoag LLP, in the firm’s health care practice group.
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EDUCATION:
Bachelor of Arts in History, Williams College
Juris Doctor, Georgetown University Law School
Master of Public Health, Harvard UniversityASSOCIATION MEMBERSHIPS:
Member, Food and Drug Law Institute -
PROFESSIONAL EXPERIENCE
Deputy Chief of Staff, FDA
FDA Detailee, Senate HELP Committee
Acting Director, OUDLC, Office of Compliance, CDER, FDA
Associate, Foley Hoag LLP
Regulatory Counsel, Office of Regulatory Policy, CDER, FDALEADERSHIP POSITIONS
Board of Directors, Healthy.io
Advisory Board, Ro
Patient Advisory Board, Comanche BioPharmaAREAS OF EXPERTISE
Regulatory policy
Regulatory compliance and enforcement
Expert witness and litigation support