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News

After a long and winding road, FDA finalizes much-debated “intended use” rule

On August 2, 2021, the U.S. Food and Drug Administration (FDA) published a final rule to amend its “intended use” regulations, codified at 21 CFR § 801.4 for medical...

News

In sharp rebuke to Trump Administration, HHS notice ending Unapproved Drugs Initiative is withdrawn

On November 20, 2020, the U.S. Department of Health and Human Services (HHS) had announced that the Department was terminating the Food and Drug Administration’s (FDA) M...

News

FDA ups OTC monograph facility fees 45% for FY 2021, with exemption for some hand sanitizer makers

In today’s Federal Register, the U.S. Food and Drug Administration (FDA) updated and reissued the rates for over-the-counter (OTC) monograph drug user fees for fiscal year (FY) 2021....

News

Biden Issues wide-ranging Buy American Executive Order – FAR rulemaking to come

On 25 January 2021, President Biden issued his first Buy American Executive Order (EO), titled Ensuring the Future Is Made in All of America by All of America’s Workers, which is...

News

HHS forces FDA to withdraw notice for OTC user fees and creates new exemptions

On January 6, 2021, the U.S. Department of Health and Human Services (HHS) ordered the Food and Drug Administration (FDA) to “cease further collection efforts” related to the...

Insights

Court of Justice clarifies cosmetics labelling requirements in the EU
Registered Content

In a judgment on 17 December 2020, the Court of Justice of the European Union (EU) provided a preliminary ruling on consumer information for cosmetic products according to Regulation (EC)...

News

HHS ends FDA Unapproved Drugs Initiative, seeks to limit which drugs require FDA approval

On November 20, 2020, the U.S. Health and Human Services Department (HHS) announced that the Department was terminating the Food and Drug Administration’s (FDA) Marketed Unapproved...

News

EC working group provides guidance concerning COVID-19 product claims on cosmetic products

On 12 November 2020, the European Commission’s Sub-Working Group on Borderline Products published a technical document concerning product claims related to leave-on hydro alcoholic...

News

Comment period ending for proposal to automatically sunset HHS/FDA/CMS regulations

The Department of Health and Human Services (HHS) recently published a proposed rule that would establish automatic sunset (expiration) dates for a potentially large number of regulations...

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