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Regulatory Update | 14 May 2012

Brazil: Anvisa Restructuring to Meet Social, Economic Development Goals

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The Chief Executive of Brazilian regulatory authority Anvisa says the ongoing restructuring process at the agency is focused on the economic and social development of the country.The agency reforms Read More...

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Anvisa

Barbano

Brazil

Goals

Restructuring

GAO: Medical Device Reviews Taking Longer Despite FDA Meeting Goals

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The US Government Accountability Office (GAO) released a report Thursday (29 March) indicating it found the US Food and Drug Administration (FDA) to be meeting its performance goals for medical device Read More...

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510(k)

FDA

GAO

Goals

MDUFA

Medical Device

Performance

PMA

report

Review

submission

time

CDRH Releases 2012 Strategic Priorities, Looks to Boost Innovation With New Regulatory Pathway and Regulatory Science

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The US Food and Drug Administrations (FDA) Center for Devices and Radiological Health (CDRH) released their strategic priorities for the coming year on 24 January 2012. The priorities consist of four Read More...

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CDRH

Draft Guidance

FDA

Goals

Guidance

Innovation Pathway

regulatory science

Strategic Priorities

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Brazil: Anvisa Restructuring to Meet Social, Economic Development Goals

GAO: Medical Device Reviews Taking Longer Despite FDA Meeting Goals

CDRH Releases 2012 Strategic Priorities, Looks to Boost Innovation With New Regulatory Pathway and Regulatory Science

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