Bill of Health

NOVEMBER 17, 2022

Fulfillment of Postmarket Commitments and Requirements for New Drugs Approved by the FDA, 2013-2016. Reforming the World Health Organization’s Essential Medicines List: Essential but Unaffordable. Limitations on the Capability of the FDA to Advise. JAMA Intern Med. 2022 Oct 3:e224226. N Engl J Med.

FDA 189

FDA World Health Medicaid Medicaid 189

SQA

AUGUST 8, 2023

TR 43 was originally published in 2007 and revised in 2013 to address industry feedback. Although this Toolkit provides PCPCs current thinking on MoCRA, companies should be mindful that MoCRA represents meaningful new authorities that FDA has yet to interpret and apply. TR 43 applies solely to empty glass containers.

FDA 40

FDA Compliance COVID-19 World Health 40

SQA

AUGUST 8, 2023

TR 43 was originally published in 2007 and revised in 2013 to address industry feedback. Although this Toolkit provides PCPC’s current thinking on MoCRA, companies should be mindful that MoCRA represents meaningful new authorities that FDA has yet to interpret and apply. TR 43 applies solely to empty glass containers.

FDA 40

FDA Compliance COVID-19 World Health 40

SQA

AUGUST 1, 2024

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

FDA Licensing Compliance World Health 40

Drug & Device Law

MAY 11, 2023

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

FDA COVID-19 Public Health World Health 59