Previous Blogs

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By Di Wu

December 17, 2019

The FDA’s Center for Devices and Radiological Health (CDRH) released four final guidance documents on Thursday, Sept. 12, which provides the FDA’s current thinking on the Special 510(K) program, the Abbreviated 510(K) program, how to format Traditional and Abbreviated 510(K)s and the new Refuse to Accept policy for 510(K).

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By West's Regulatory Affairs Team

April 07, 2016

West has recently converted its Elastomer Formulation Drug Master Files (DMFs) to an electronic (eCTD) format.

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By Lauren Orme, PMP

April 04, 2016

The International Conference on Harmonisation (ICH) has issued Guidelines for Elemental Impurities to limit patient exposure to potentially toxic elements above a specified limit during their course of treatment. 

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By West's Regulatory Affairs Team

November 06, 2015

West’s customers are very familiar with our Drug Master Files (DMFs) and Letters of Authorization. West maintains some of the most active DMFs held by the FDA and Health Canada, and we’ve provided customers with over 9,000 LOAs since 2008.

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By Jeanette Hampe

August 13, 2015

Because differences exist between regulatory agencies from region to region, West regulatory affairs continually stays informed of new developments and changes in order to provide customers with accurate regulatory support regarding packaging requirements.