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FDA Insists Its Quality Controls Are Up To The Task

 
• By Dave Wallace

Commissioner Scott Gottlieb and center for drug evaluation and research (CDER) director Janet Woodcock have insisted that the FDA is maintaining “strong oversight of generic drug quality issues domestically and abroad”.

Quality
Patients And Consumers Should Feel Confident About The FDA’s Quality Controls, The Agency Says • Source: Shutterstock

Allegations of substandard quality controls are not a new phenomenon for the generics industry. However, it is rare for an industry regulator to produce as comprehensive and pointed a response to such criticism as has just been published by the US Food and Drug Administration (FDA).

In a lengthy statement – apparently positioned as a rebuttal to media coverage suggesting deficiencies in the FDA’s quality oversight...

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