FDA Intends To Cut Generic Drug Application Review To Ten Months


Maher Law Firm / www.maherlawfirm.com /

Maher Law Firm

CNBC (2/25) reported that in a television interview, “FDA’s Margaret Hamburg” addressed the “backlog of generic drug applications at the Food & Drug Administration.” She said, “We frankly are taking too long to review important applications, and we want to help get those products out.” Hamburg aims “to bring the median review time of generic applications from the current average of approximately 30 months — down to a primary review goal of 10 months for unamended applications.”

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