Posts tagged Abbreviated New Drug Application.
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FDA Releases Guidance to Assist the Development of Advanced Technology to Modernize Pharmaceutical Manufacturing
Categories: FDA, Pharmaceuticals
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On December 23, 2015, the Food and Drug Administration's (FDA) released draft guidance on the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base. This was a positive step towards helping pharmaceutical companies invest and implement emerging technologies that improve overall drug quality.

Pharmaceutical companies have spent millions of dollars issuing recalls for products because of a variety of quality issues caused by outdated manufacturing technologies. These issues have caused significant delays in providing ...

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