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By Jia Min Boo

八月 06, 2020

In 2011, the US FDA issued an advisory regarding the potential formation of glass lamellae in vials containing injectable drugs. This was in response to several drug recalls in 2010-11. The number of glass-related drug recalls has since declined greatly. This no doubt is due to key actions taken by pharmaceutical manufacturers before the drug goes to market, even during the development phases.

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By Di Wu

十二月 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 Ana Ladino

十月 16, 2018

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2019. The Federal Food, Drug and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2019, which apply from October 1, 2018, through September 30, 2019.