ARTICLES BY KALAH AUCHINCLOSS
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FDA Issues Final Rule On Intended Use For Drugs & Devices After A Complicated History9/10/2021
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?
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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.