News & Analysis as of

Warning Letters › Enforcement Actions › Department of Health and Human Services (HHS)

Skadden, Arps, Slate, Meagher & Flom LLP

Joint FDA/HHS Initiative Targeting Direct-to-Consumer Pharmaceutical Advertising Garners Much Attention, but Legal Basis and...

Skadden, Arps, Slate, Meagher & Flom LLP on

On September 9, 2025, the Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) announced a new initiative to close what the agencies describe as a “loophole” in requirements regarding the...more

Sheppard Mullin Richter & Hampton LLP

FDA’s Vast Ad/Promo Warning – Enforcement Ramp-Up or PR Nothingburger?

Sheppard Mullin Richter & Hampton LLP on

Late Tuesday, FDA issued a press release warning that it would be sending “thousands of letters warning pharmaceutical companies to remove misleading ads and issue approximately 100 cease-and-desist letters to companies with...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 4. In This Month's E-News: April 2020

Health Care Compliance Association (HCCA) on

Report on Research Compliance 17, no. 4 (April 2020) The Food and Drug Administration has accused a University of Michigan physician and professor of conducting research for more than three years after his approval from the...more

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