Luis Jimenez

Pathways

Australian Prescription Medicine Pathways – Project Orbis

Project Orbis is an initiative of the US FDA Oncology Centre of Excellence (OCE). The intent of Project Orbis is to provide a framework for concurrent submission and review of...
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TGA Advertisement Framework Revisions Hard at Work During Pandemic Times

Marking the second year after the issuance of the revised TGA Advertising framework, the TGA has evidenced a strong hard-line position on enforcements against the illegal import, supply, and advertising...
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FAQs Regarding the Australian R&D Tax Incentive and Regulatory Services

The Australian R&D Tax Incentive and Regulatory Services As we navigate through the global pandemic of COVID-19, Australian R&D Tax Incentives continue to be of significant relevance for companies exploring...
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Notified Body Updates for MDD, MDRs, IVDD and IVDR

This article is current as at 29 April 2020 The European Parliament has voted to postpone the implementation deadline for MDR from May 2020 to May 2021. This gives a...
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TGA expedites COVID-19 approvals, while keeping up business as usual for other devices

The TGA continues to provide timely responses and support for new applications and emergency use applications. Our firm continues to be in active communication with the agency, which at the...
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EC Acts Quickly – and issues proposal to delay MDR deadline amidst COVID Pandemic

With sweeping speed, the European Commission (EC) has issued its proposal to postpone the deadline of the transition from MDD to MDR. The goal is to have the European Parliament...
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2019 US 510(k) Clearances Analysis and FDA’s target to receive innovative technologies first in 2020

We have recently been covering several new initiatives at the United States FDA CDRH, and as such thought it would be fitting to provide a round-up for the 510(k) activities...
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A single review program for medical devices?

During this year’s Bio-Utah Summit in November 2019, Dr. Jeffrey Shuren, Director of the FDA’s Center for Devices and Radiological Health (CDRH) spoke about the new initiatives and modernization of...
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And so starts the MDR/Brexit fallout… First LRQA and now QS Zurich fall by the wayside

Breaking News: As of June 13th, Lloyds Register Quality Assurance (LRQA) withdrew from MDD and IVDD services (see the announcement here). It's official, the first notified body based in UK...
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TGA will no longer send “friendly reminders” for Annual Reports.

In a communication on May 15th, TGA announced they will no longer be providing courtesy formal correspondence requesting annual reports from Australian Sponsors, and failing to provide annual reports may...

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