Securities and Exchange Commission (SEC), Food and Drug Administration (FDA), Insider Trading

New SEC Leadership Signals Continued Focus on FDA-Related Disclosures

McDermott Will & Schulte on 3/21/2025

Lawyers inside and outside the US Securities and Exchange Commission (SEC) have speculated that the agency’s new leadership will take a “lighter touch” when it comes to enforcement. The ultimate approach of the new SEC...more

Insider Trading Based on Clinical Trial Information Remains Area of Vulnerability

ArentFox Schiff on 5/10/2023

For decades, the Securities and Exchange Commission (SEC) and criminal prosecutors have pursued claims for insider trading in securities by persons who learn material nonpublic information about clinical drug trials. Every...more

SEC Brings Regulation FD Action

Mayer Brown Free Writings + Perspectives on 8/26/2019

On August 20, 2019, the SEC charged a pharmaceutical company with violations of Regulation FD based on its sharing of material, nonpublic information with sell-side research analysts on two separate occasions without also...more

SEC Brings Enforcement Action against TherapeuticsMD for Violations of Regulation FD

Herbert Smith Freehills Kramer on 8/26/2019

On Aug. 20, 2019, the Securities and Exchange Commission (SEC) announced that it had charged public pharmaceutical company TherapeuticsMD, Inc. for violations of Regulation FD and Section 13(a) of the Exchange Act related to...more

SEC Signals New Phase of Regulation FD Enforcement

Ballard Spahr LLP on 8/21/2019

The United States Securities and Exchange Commission (SEC) announced yesterday, August 20, 2019, that it charged TherapeuticsMD, Inc., a pharmaceutical company headquartered in Boca Raton, Florida, with violations of...more

SEC Charges Issuer for Reg FD Violation for Selective Disclosure to Analysts

Stinson - Corporate & Securities Law Blog on 8/21/2019

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 research analysts...more

For congressional overseers, red flags fly over issues at FDA

Patrick Malone & Associates P.C. | DC Injury... on 6/23/2016

Congressional overseers of the federal agency that regulates drugs and medical devices have gotten red-flag warnings about problems at the Food and Drug Administration, including: two separate calls for improvements from...more

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