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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

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

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

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...

News

FDA, CMS actions on drug importation promise much, likely deliver little

Recently, the U.S. Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) announced policies intended to permit the importation of, and Medicaid...

News

FDA proposes clarification in long-running tussle over “intended use” rules for drugs and devices

On September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule to modify its intended use regulations to clarify the types of evidence FDA will consider when...

News

COVID-19 Report for Life Sciences and Health Care Companies (21 - 24 September 2020)

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in...

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