News & Analysis as of

Disclosure Requirements Compliance Food and Drug Administration (FDA)

Cozen O'Connor

FDA Transparency Push: CRLs Released

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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

Ropes & Gray LLP

FDA Commissioner Makary Promises “Real Time” Release of Complete Response Letters: Can FDA Really Do That?

Ropes & Gray LLP on

On July 10, 2025, in the name of embracing “radical transparency,” the U.S. Food and Drug Administration (“FDA”) announced that it was publishing more than 200 complete response letters (“CRLs”) issued in response to drug and...more

King & Spalding

FDA Publishes More Than 200 Complete Response Letters (CRLs) With More to Come

King & Spalding on

On July 10, 2025, the Food and Drug Administration (FDA) announced that it had published more than 200 complete response letters (CRLs), in response to applications submitted to the FDA for approval of drugs or biological...more

Gardner Law

Exercise Caution: Celebrity Endorsements of Medical Products

Gardner Law on

Celebrity Endorsements - As companies continue to seek effective advertising strategies, celebrity endorsements remain a powerful tool, particularly in reaching broad and receptive audiences through social media platforms....more

Goodwin

How to (Finally) Get Your SIUU Out: FDA Issues Final Guidance on Communicating Off-Label Scientific Information

Goodwin on

On January 7, 2025, FDA announced the availability of a final guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...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

Gardner Law

FDA Faces Pressure to Enhance Oversight of Online Prescription Drug Promotions

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The U.S. Food and Drug Administration (FDA) is facing pressure from Congress and the medical community to enhance its oversight of online prescription drug advertising. The pressure comes amidst growing concerns about social...more

Mintz - Health Care Viewpoints

Colorado AI Systems Regulation: What Health Care Deployers and Developers Need to Know

As the first state law to regulate the results of Artificial Intelligence System (AI System) use, Colorado’s SB24-205, “Concerning Consumer Protections in Interactions with Artificial Intelligence Systems” (the Act), has...more

Arnall Golden Gregory LLP

Open Up Your Eyes: FDA Expects Real Transparency in ClinicalTrials.gov Disclosures

Based on client inquiries and FDA actions, the Food and Drug Administration is focusing more on companies not submitting data to www.ClinicalTrials.gov. It is taking stronger action against those companies it believes are...more

King & Spalding

OIG Increases Expectations for Compliance Officers in Its New Compliance Program Guidance – What Compliance Officers at...

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On November 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued its anticipated General Compliance Program Guidance (“GCPG”) for the health care industry. The GCPG serves as a...more

McDermott Will & Emery

After Almost 25 Years, FTC Issues New Health Products Compliance Guidance

McDermott Will & Emery on

The Federal Trade Commission (FTC) announced its Health Products Compliance Guidance on December 20, 2022. The 2022 guidance updates and replaces the FTC’s 1998 guidance, Dietary Supplements: An Advertising Guide for...more

Hinch Newman LLP

Advertising Law Alert: FTC Announces New Health Products Compliance Guidance

Hinch Newman LLP on

In December 2022, the the Federal Trade Commission published new guidance regarding representations about the benefits and safety of health-related products: Health Products Compliance Guidance. Federal Trade Commission...more

Venable LLP

FTC Announces Health Products Compliance Guidance

Venable LLP on

On December 20th, 2022, the Federal Trade Commission published new guidance regarding claims about the benefits and safety of health-related products: Health Products Compliance Guidance. This guidance replaces the...more

Foley & Lardner LLP

Top Legal Issues Facing the Manufacturing Sector in 2022

Foley & Lardner LLP on

As the global economy faces the third year of the pandemic, manufacturers are no longer focused on figuring out when things will return to “normal.” Instead, they are applying lessons learned from the past few years to become...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

Neal, Gerber & Eisenberg LLP

Client Alert: FTC and FDA Team Up to Send Warning Letters About Social Media Influencer Posts

Recently, the Federal Trade Commission (“FTC”) and the U.S. Food & Drug Administration (“FDA”) issued joint warning letters to four sellers of e-liquids, the nicotine “juice” used in vaping regarding their use of social media...more

McNees Wallace & Nurick LLC

FDA Extends Compliance for Restaurant Food Labeling and Seeks Additional Comments

The Food and Drug Administration (FDA) has extended the compliance date for the final rule requiring disclosure of certain nutrition information for standard menu items in certain restaurants and retail food establishments....more

Holland & Knight LLP

Food and Beverage Law Update: October 2015

Holland & Knight LLP on

Labor and Employment - Plaintiff Wage and Hour Lawsuits Continue to Climb - Wage and hour litigation has become what some call the new "workplace revolution." Data from the Federal Judicial Center indicates that...more

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