News & Analysis as of

Enforcement Actions Disclosure Requirements Food and Drug Administration (FDA)

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

Arnall Golden Gregory LLP

Let’s Get Clinical: FDA Issues NOV Regarding Misleading Clinical Data Promotion

When the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued a recent Notice of Violation (“NOV”), some of us were humming, “Let’s get clinical,” to the tune of Olivia Newton-John’s 1982 hit...more

McDermott Will & Schulte

New SEC Leadership Signals Continued Focus on FDA-Related Disclosures

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

McCarter & English, LLP

FDA Finalizes Guidance on Communications Regarding Unapproved Uses of Medical Products

In January 2025, the US Food and Drug Administration (FDA) finalized its 2023 revised draft guidance Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more

Morgan Lewis - As Prescribed

Clinicaltrials.gov: Recent Action May Signal Increased Attention from FDA on Trial Data Reporting Compliance

The US Food and Drug Administration (FDA) recently issued a notice of noncompliance to the FADOI Foundation, citing the organization’s failure to submit required clinical trial results to ClinicalTrials.gov. The notice...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: November 2024

On the heels of a $7.6 million payment by Cleveland Clinic to settle allegations of False Claims Act (FCA) violations and unallowable sharing of passwords, Michael Lauer, NIH deputy director for extramural research, penned a...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

Arnall Golden Gregory LLP

FDA is (Once Again) Keeping Up with the Kardashians: A Cautionary Tale Involving Endorsements, Testimonials and Influencer...

In March, Khloe Kardashian unwittingly joined her sister, Kim Kardashian, as the subject of a Food and Drug Administration (FDA) Warning Letter relating to the reality star’s influencer-marketing activities. ...more

Foley & Lardner LLP

Selective Disclosure Violation Results in SEC Order

Foley & Lardner LLP on

Recently, the Securities and Exchange Commission (SEC) issued an order charging a publicly traded pharmaceutical company with violations of Regulation FD as a result of selectively disclosing material, nonpublic information....more

Dorsey & Whitney LLP

SEC Files First Reg FD Action In Years

Dorsey & Whitney LLP on

Regulation Fair Disclosure was passed in 2002 to fill what many saw as a regulatory gap – the selective disclosure of material non-public information by issuers.  Essentially the Regulation – now known as Reg FD – requires a...more

Mayer Brown Free Writings + Perspectives

SEC Brings Regulation FD Action

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

Herbert Smith Freehills Kramer

SEC Brings Enforcement Action against TherapeuticsMD for Violations of Regulation FD

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

Ballard Spahr LLP

SEC Signals New Phase of Regulation FD Enforcement

Ballard Spahr LLP on

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

Stinson - Corporate & Securities Law Blog

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

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

Mintz - Health Care Viewpoints

Are HCT/Ps a Dark Spot in the Sunshine Act Requirements?

On February 22, the Wall Street Journal published an article about the tissue graft manufacturer MiMedx Goup, Inc. and its failure to report payments to physicians under CMS’s Open Payments Program established by the Centers...more

Cadwalader, Wickersham & Taft LLP

2016 Year In Review: Securities Litigation And Regulation

2016 was an active year in securities litigation. In the first half of 2016 alone, plaintiffs filed 119 new federal class action securities cases. It was also a busy year for SEC enforcement proceedings, with a record 868...more

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