Kalah Auchincloss

Kalah Auchincloss, J.D., M.P.H., is SVP of regulatory compliance and deputy general counsel for Greenleaf Health. She 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. At Greenleaf, Auchincloss advises pharmaceutical and medical device companies on compliance, policy, and other issues. Before moving to Greenleaf, Auchincloss spent six years at the FDA, most recently as deputy chief of staff, but also serving in CDER’s Office of Compliance and Office of Regulatory Policy. You can contact her at kalah.auchincloss@greenleafhealth.com.

ARTICLES BY KALAH AUCHINCLOSS

The 8 Key Takeaways For FDA Inspections In The Food And Drug Omnibus Reform Act
2/7/2023

With President Biden’s signature, the Food and Drug Omnibus Reform Act of 2022 (FDORA), part of the larger Consolidated Appropriations Act of 2023, became law on Dec. 29, 2022. FDORA expands and modifies the inspection authority of the FDA in several key areas, including alternative tools to inspection, mutual recognition agreements, bioresearch monitoring, and more.
Congressional Bill Supports Advanced And Continuous Manufacturing
1/5/2022

The House recently passed H.R. 4369, which authorizes $100 million over four years to establish National Centers of Excellence in Advanced and Continuous Manufacturing at U.S. academic institutions. This article delves into the news and how it fits into other U.S. initiatives supporting the field.
FDA's Final Rule On Intended Use For Drugs & Devices
9/10/2021

On Sept. 1, 2021, the FDA’s final rule on intended use for drugs and devices became effective. The rule has a complicated history and has been the subject of controversy over the last 6 years. It provides clarity to manufacturers, but many remain dissatisfied with the evidentiary standard for determining intended use. Might legal challenges follow?
The “Resiliency Roadmap” — Next Steps For FDA Inspections
6/11/2021

More than a year into the COVID-19 pandemic and FDA’s abrupt suspension of on-site inspections in March 2020, the agency released the Resiliency Roadmap for FDA Inspectional Oversight in May 2021. This article examines how this news affects the pharmaceutical, biotech, and medical device industries.
FDA Inspections: Are Changes On The Horizon?
4/2/2021

A year into the pandemic, the FDA is still conducting only limited inspections in the U.S. and evidence has emerged of a significant inspection backlog that could compromise the safety and quality of the U.S. drug supply. Kalah Auchincloss of Greenleaf Health provides a brief timeline of inspection-related events over the last year, discusses the impact, and examines the changes that we might expect as the FDA begins to shift back to normal operations.