Kalah counsels a broad array of 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 as a former consultant and attorney to advise clients on regulatory policy, compliance, enforcement, and other actions. Most recently, Kalah spent 8 years as a consultant to major pharma, biotech and medical device companies providing strategic regulatory advice.

Prior to her consulting and legal roles, 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.

• FDA Deputy Chief of Staff

• FDA Senate HELP Detailee

• Director, FDA CDER OUDLC

• Regulatory Counsel, FDA CDER ORP

• Principal at major consulting firm, representing numerous biotech, medical device, investor and other clients

• FDA Associate at well respected law firm

• Harvard University, MPH, 2011

• Georgetown University Law Center, JD, 2006, magna cum laude

• Williams College, BA, 2001, cum laude

• District of Columbia

• Massachusetts