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Disclosure Requirements › Abbreviated New Drug Application (ANDA) › Enforcement Actions

Cozen O'Connor

FDA Transparency Push: CRLs Released

Cozen O'Connor on

On July 10, 2025, citing a drive to increase transparency, the Food and Drug Administration (“FDA”) published more than 200 complete response letters (CRLs) previously issued to companies that had submitted new drug...more

Bass, Berry & Sims PLC

Recent SEC Enforcement Action Drives Home the Importance of Regulation FD Policies and Training

Bass, Berry & Sims PLC on

On August 20th, 2019, the SEC charged TherapeuticsMD Inc., a pharmaceutical company headquartered in Boca Raton, Florida, with violations of Regulation FD based on its sharing of material, nonpublic information with sell-side...more

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