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Monthly Round-Up of What to Read on Pharma Law and Policy

Bill of Health

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. Value Health. JAMA Intern Med. 2022 Oct 3:e224226.

FDA 190
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SQA Regulatory Surveillance Summary | Monthly Update 2023 – May And June

SQA

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