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Previous Blogs

Analytical Lab Testing
Integrated Solutions Program Glass Delamination FDA Daikyo Crystal Zenith Cyclic Olefin
West's Integrated Solutions - Reducing Risks

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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Guidance Icon with open book and finger pointing
Regulatory Affairs FDA Guidances and Regulations Medical Devices 510(K)
The FDA released four final guidances pertaining to the 510(K) program

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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SmartDose Injection Platform in Use
FDA Medical Device User Fee
Medical Device User Fee Rates

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.

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