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27

Gen

A look at FDA’s data on priority and competitive generics

Three years into the second Generic Drug User Fee Amendments (GDUFA II) program, the US Food and Drug Administration (FDA) has seen the number of priority and competitive generic therapy (CGT) abbreviated new drug applications (ANDAs) approved or under review rise as generic drugmakers continue to pursue both designations....[FDA-RAPS]

27

Gen

A look at FDA’s data on priority and competitive generics

Three years into the second Generic Drug User Fee Amendments (GDUFA II) program, the US Food and Drug...

27

Gen

Biden Issues Executive Order on US-Based Manufacturing

President Joe Biden issued a “Made in America” executive order this week for federal procurement...

27

Gen

Japan’s PMDA shares process for certain remote inspections

The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has published its procedure for conducting...

27

Gen

FDA Inspections down in 2020, but CDER hit most goal dates

During the pandemic, the US Food and Drug Administration (FDA) continued to attempt to meet goals...

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