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SQA Regulatory Surveillance Summary for March and April 2024

SQA

The adoption of these mechanisms is recommended and encouraged by the World Health Organization (WHO) so that the population has faster access to health services and technologies. In addition, the ISPE Guide outlines the authority of State Boards of Pharmacy and their coordination of oversight with the FDA.

FDA 40
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FDA’s Brief To The Fifth Circuit in the AHM Case Is Worth A Read

Drug & Device Law

A perusal of amicus briefs drew more than a few “they should know what they are talking about here” responses to groups of food and drug law scholars (as opposed to DDL bloggers), former FDA commissioners, former FDA officials, and former DOJ officials, among others. The appellate brief from FDA bears that out well.

FDA 59