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Abbreviated New Drug Application (ANDA) Civil Monetary Penalty

Wilson Sonsini Goodrich & Rosati

Recent SEC Order Serves as a Reminder of the Importance of Regulation FD Compliance Programs

On August 20, 2019, the U.S. Securities and Exchange Commission (SEC) issued a cease-and-desist order against TherapeuticsMD, a pharmaceutical company, finding that it violated Regulation FD and Exchange Act Section 13(a),...more

King & Spalding

Congress Acts to Eliminate MDRP Misclassification

King & Spalding on

President Trump on Thursday signed into law the most extensive set of amendments to the Medicaid Drug Rebate Program statute since the Affordable Care Act in 2010. The new law addresses the perception that drug manufacturers...more

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