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News

FDA publishes long-awaited clinical trial diversity guidance

29 June 2024

The U.S. Food and Drug Administration (FDA) has issued its long-awaited draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations ...

News

FDA publishes long-awaited clinical trial diversity guidance

28 June 2024

The U.S. Food and Drug Administration (FDA) has issued its long-awaited draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations ...

News

FDA summarizes LDT rule requirements in new compliance guide

27 June 2024

The U.S. Food and Drug Administration (FDA) announced yesterday a “Small Entity Compliance Guide” (SECG) for Laboratory Developed Tests (LDTs), aiming to assist small...

News

First salvo fired against FDA’s laboratory developed test rule

06 June 2024

In the Eastern District of Texas U.S. federal court, the American Clinical Laboratory Association (ACLA) and its member company, HealthTrackRx, have filed a lawsuit against the Food and...

Insights and Analysis

European Parliament Elections 2024: Explainer and Policy Takeaways

04 June 2024

As the EU gears up for its upcoming elections, stakeholders across sectors are closely monitoring potential shifts in policy and governance. With an anticipated right-ward shift of the...

News

FDA finalizes guidance on “Remanufacturing” vs “Servicing”

30 May 2024

The U.S. Food and Drug Administration (FDA) has finalized its guidance on “Remanufacturing of Medical Devices,” clarifying the point when manipulation or repair of a medical...

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UK MHRA publishes blueprint for the international recognition of medical devices

21 May 2024

The UK Medicines and Healthcare products Regulatory Agency (MHRA's) has published a Statement of policy intent: international recognition of medical devices outlining its proposal for...

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Scrutiny on health care professional transparency and inducement in the Netherlands

08 May 2024

On 8 April 2024, the Dutch Minister of Medical Care sent a letter to Dutch Parliament (in Dutch: “Tweede Kamer”) regarding interactions between life sciences companies and...

Insights and Analysis

Life Science Law Update – Key developments for pharma & device companies in EU

07 May 2024

The Q1/24 Life Science and Health Care Law Update covers key trends across EU life sciences regulatory, corporate, compliance, competition, and privacy.Key new developments: Pharma: EC ...

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