The U.S. Food and Drug Administration (FDA) has taken formal steps to prevent and mitigate drug shortages for over a decade. While the problem predates the COVID-19 pandemic, the pandemic presented potential new challenges...more
A recent Federal Circuit court decision promises to significantly impact and broaden the scope of the types of foreign-produced pharmaceutical products companies can sell to the U.S. government.
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The European Union (“EU”) and the United States (“US”) have reached a sectoral agreement (the “Agreement”) that will greatly ease the administrative burden when proving compliance with Pharmaceutical Good Manufacturing...more
On January 5, 2017, the U.S. Department of Health and Human Services (“HHS”) and the Health Resources and Services Administration (“HRSA”) issued a final rule on the calculation of drug ceiling prices under the 340B Drug...more
On August 12, 2016, the Health Resources and Services Administration (“HRSA”) released a notice of proposed rulemaking (the “Proposed Rule”) to formally regulate the administrative dispute resolution (“ADR”) process for...more