Search Results for Appeals

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FDA Proposes Rule for Appealing CDRH Decisions By Michael Mezher - Published 16 January 2018

The US Food and Drug Administration (FDA) on Tuesday proposed a new rule for appealing certain decisions about medical devices made by the Center for Devices and Radiological Health (CDRH).

Categories: News, US, CDRH, Medical Devices, Submission and registration

Tags: Significant Decisions, Supervisory Review, Appeals

CDRH Finalizes Appeals Process Guidance, Adding New 'Significant Decision' Category By Alexander Gaffney, RAC - Published 01 August 2014

The US Food and Drug Administration (FDA) this week released a final version of a guidance on the Center for Devices and Radiological Health's (CDRH) appeals process.

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices, Regulatory strategy

Tags: Guidance, Final Guidance, 517A, CDRH Appeals Process

FDA Attitude on Off-Label Prescribing Central to Arizona Abortion Drug Access Case By Alexander Gaffney, RAC - Published 04 June 2014

A federal court has ruled that Arizona's attempts to limit access to an abortion drug known as RU-486 (mifepristone) are unconstitutional, drawing on the US Food and Drug Administration's (FDA) authority to support its ruling.

Categories: News, US, FDA, Drugs, Labeling

Tags: Judge, Court, Ninth Circuit Court of Appeals, RU-486, Mifepristone, Abortion, Off-Label, Off-Label Prescribing

China's FDA Announces New Administrative Review Process By Louise Zornoza, RegLink - Published 13 November 2013

Categories: China, CFDA

Tags: Appeals Process

Long-Awaited Guidance on CDRH's Appeals Process Released, Alleviating Some Industry Concerns By Alexander Gaffney, RF News Editor - Published 16 May 2013

Categories: US, FDA, CDRH

Tags: Appeals, Petition, guidance, medical device

Demystifying the FDA Appeals Process By Yoon Hee Hong and David Lim, PhD, RAC, CQA - Published 18 October 2012

For more than a decade, there has been confusion about the appeals process at the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH). There are several avenues to file an appeal, each with specific requirements. This article aims to clarify the CDRH appeals process so stakeholders can use it effectively. The relevant processes for FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) also are described in this article.

Categories: Features, FDA, CBER, CDER, CDRH

Tags: Appeals Process, Appeals, application

Responsible Corporate Officer Doctrine Upheld by Appeals Court By Alexander Gaffney - Published 30 July 2012

Tags: Purdue, DC Court of Appeals, Responsible Corporate Officer, Park Doctrine, Court, Latest News

Court Upholds FDA Labeling Regulations on Cigarette Packaging By Alexander Gaffney - Published 20 March 2012

Categories: FDA, Labeling

Tags: Graphic, 6th Circuit, Cincinnati Court of Appeals, Court, Law, Latest News, Tobacco, advertising, regulatory