FDA Forewarns Of User Fee Goal Delays As It Focuses On COVID-19 Drugs

By Beth Wang / May 27, 2020 at 6:50 PM
FDA anticipates it may not be able to continue meeting its prescription drug and biosimilars user fee goal dates, as many of its staff members are focusing on COVID-19 activities, the agency says in guidance published Tuesday (May 26) . In response to the pandemic, the agency intends to allocate resources to applications for investigational drug products, new drugs and biologics, and it will consider prioritizing generic drug application reviews if the products can help address the public health emergency...


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