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

Bill of Health

Frequency, Characteristics, And Outcomes Of Negative Advisory Committee Votes For FDA-Approved Drugs. Fixing The FDA’s Orange Book. The global impact of COVID-19 on drug purchases: A cross-sectional time series analysis. The global impact of COVID-19 on drug purchases: A cross-sectional time series analysis.

COVID-19 208
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SQA Regulatory Surveillance Summary | Monthly Update 2023 – May And June

SQA

Experience with large-scale events such as Hurricane Maria and the COVID-19 pandemic, and more recent geopolitical events, have cast a wider lens on global supply chain and distribution vulnerabilities. The model provides expanded guidance that reflects new insight and best practices that have emerged in the past several years.

FDA 40
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SQA Regulatory Surveillance Summary | Monthly Update 2023 – May And June

SQA

Experience with large-scale events such as Hurricane Maria and the COVID-19 pandemic, and more recent geopolitical events, have cast a wider lens on global supply chain and distribution vulnerabilities. The model provides expanded guidance that reflects new insight and best practices that have emerged in the past several years.

FDA 40
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A Texas Mess

Drug & Device Law

So we do have comments on the bizarre complaint that the Texas attorney general recently filed over COVID-19. The complaint, brought under the Texas consumer protection statute, sued a major manufacturer of COVID-19 vaccine that was used to control the recent pandemic. FDA (8/23/21) press release (emphasis original).