Kalah Auchincloss

Executive Vice President, Regulatory Compliance and Deputy General Counsel
Greenleaf Health, Inc.
 

 

Kalah Auchincloss has more than a decade of food and drug legal, policy and regulatory experience at the FDA, on Capitol Hill and in the private sector. She spent six years at the FDA, most recently as deputy chief of staff for two FDA commissioners: Dr. Robert Califf and Dr. Scott Gottlieb. As deputy chief of staff, Ms. Auchincloss 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. She 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, Ms. Auchincloss 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.

 

Sessions: 

Welcoming Remarks
Mock Inspection: Practice Makes Perfect
Opening Comments by Committee Chair
Communicating with the FDA: How to Facilitate an Inspection Post-COVID 
Panel Discussion: The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site