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Regulatory Oversight › Prescription Drugs › Product Labels

Davis Wright Tremaine LLP

Stay ADvised: 2025, Issue 6

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Reckitt Benckiser Tastes Sweet Success as Mucinex Honey False Ad Dismissed - Plaintiffs alleging that Reckitt Benckiser falsely advertised certain Mucinex products as containing honey failed to sufficiently allege that the...more

Alston & Bird

FDA Proposes to Overhaul Labeling Requirements for Approved or Conditionally Approved New Animal Drugs

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Nearly five decades after the FDA last reorganized animal drug labeling regulations, the agency has released a proposal to revise the requirements for the content and format of labeling for approved or conditionally approved...more

Hogan Lovells

Senate passes online country of origin labeling requirements under the USICA

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On 8 June 2021, the Senate passed the U.S. Innovation and Competition Act (USICA), which contains a wide range of provisions aimed at improving the United States’ global economic competitiveness, particularly toward China. ...more

American Conference Institute (ACI)

[Virtual Event] 36th Annual FDA Boot Camp - March 24th - 25th, 8:15 am - 1:45 pm EDT

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ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...more

Hogan Lovells

12 Years Later: Court Prohibits Marketing of Prescription Versions of OTC Drug

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In a big win for the Food and Drug Administration (FDA), the D.C. Circuit of the United States Court of Appeals reinforced FDA’s position on what constitutes a “meaningful difference” between prescription and over-the-counter...more

Hogan Lovells

FDA launches Biosimilars Action Plan to spur biologics competition, finalizes labeling guidance

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On July 18, FDA Commissioner Scott Gottlieb, M.D., announced the release of FDA’s Biosimilars Action Plan (BAP), saying it would help enable a path to competition for biologics from biosimilars, while preserving incentives...more

Hogan Lovells

FDA guidances promote greater communication to payors about medical product value, clarify CFL communications

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On June 12, FDA finalized two guidance documents regarding the types of information that drug and device manufacturers may communicate to payors and that the agency regards as “consistent with" FDA-required labeling. FDA...more

Hogan Lovells

There'll Be Some Changes Made: President Signs Prescription Drug and Biologic User Fee Reauthorization Act

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On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs,...more

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