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Regulation/Legislation (Health)

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Regulation

Set Alert for Regulation {Health}

Latest From Health & Regulation

Deference No More: More Challenges Against US FDA After Supreme Court Tosses Chevron Doctrine?

The Supreme Court’s 6-3 ruling is expected to have a minimal impact on drug approvals and other scientific determinations, but matters steeped in the interpretation of regulation and statute, such as marketing exclusivity, could face a heightened risk of challenge, legal experts say.

Legal Issues FDA

Diversity Action Plans Should Be Brief And Waiver Requests Filed Early, US FDA Says

In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.

Diversity & Inclusion Clinical Trials

Diversity Enrichment: US FDA Guidance Suggests Sponsors May Need To Overenroll Key Groups

New draft guidance on clinical trial diversity action plans pushes for disproportionately high enrollment of traditionally underrepresented groups, while also asking companies to tailor global programs to US populations and consider diversity aspects that Congress did not outline. 

Diversity & Inclusion Clinical Trials
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Legislation

Set Alert for Legislation {Health}

Latest From Health & Legislation

EU Green Claims Directive: Council Wants Lighter Touch, Especially For SMEs

The European Council adopts its negotiating position with regards to the Green Claims Directive, which aims to prevent greenwashing and empower consumers in making informed, environmentally conscious purchasing decisions. While small and medium-sized enterprises stand to specifically benefit from the Council's more flexible approach, companies in general may be allowed to make certain explicit environmental claims without third-party verification.

Europe Health

US FDA May See Second Straight Year of Non-User Fee Funding Cuts From Congress

The House Appropriations Agriculture, Rural Development, and FDA Subcommittee advanced the FDA’s fiscal year 2025 funding bill, beginning a likely long and difficult budget cycle. 

FDA Legislation

US Revamped OTC Monograph Program Changes Start With Acetaminophen Skin Reaction Warning

Proposed change is “the first FDA-initiated proposed order that was not statutorily required” by the 2020 legislation authorizing the agency’s overhaul of the program which makes the large majority of nonprescription drugs available in the US.

OTC Drugs Drug Approval Standards
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