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Time’s really up! FDA authority to crack down on regenerative medicines upheld as grace period ends

On July 9, 2021, the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) added a Q&A page on its website about the May 31 end of the grace...

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“Remanufacturing” or “Servicing”? New FDA guidance clarifies distinction for medical devices

On June 18, 2021, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Remanufacturing of Medical Devices,” which aims to help clarify the point when...

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In sharp rebuke to Trump Administration, HHS notice ending Unapproved Drugs Initiative is withdrawn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

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FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future Operations

The Food and Drug Administration (FDA or the agency) recently released a report entitled Resiliency Roadmap for FDA Inspectional Oversight (Report) recapping the inspectional activities...

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Clarification of social media laws #notanad

Recently, Ad Standards Australia (“Ad Standards”) found two social media influencers breached the Australian Association of National Advertisers (AANA) Code of Ethics...

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Time’s up: New enforcement era for regenerative medicines begins June 1

On April 21, 2021, FDA’s Center for Biologics Evaluation and Research (CBER) Director Peter Marks M.D. confirmed that the grace period intended to provide developers of regenerative...

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New U.S. Trademark Law Alert – Intellectual Property Reforms Tucked Into COVID-19 Relief Package

On December 21, 2020, Congress passed the Consolidated Appropriations Act, 2021 and the act was signed into law on December 27, 2020. But don’t let the bland title fool you. Buried...

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The coronavirus (self-)test kits for laypersons – an approach in various steps

Step by step towards self-testing: Due to the Covid-19 pandemic, which continues to impinge upon everyday life, the German Federal Ministry of Health (Bundesministerium für Gesundheit, ...

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Reforms to software-based medical devices take effect this week

The new classification rules for software-based medical devices (“SaMDs”) and personalised medical devices introduced by the Therapeutic Goods Legislation Amendment (2019...

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