Complex Generic Mid-Cycle Meetings: US FDA Suggests Taking The Date Offered
US FDA offers best practices and tips to ensure successful meetings, although few have been conducted so far.
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US FDA Asks Sponsors Of Discontinued Naloxones To Consider Return To Market
In announcing expedited assessments for new naloxone ANDAs, the agency also offers guidance to sponsors of discontinued products considering a return to marketing.
US FDA's New Paragraph IV Data Further Illustrates Generic Competition Problems
Data on the number of ANDAs submitted with valid paragraph IV certifications shows some products with strong generic interest and others with almost none.
GDUFA III May Rely Less On PDUFA As A Role Model
Meeting opportunities codified in GDUFA II were adapted from the new drug user fee program experience but may not be well suited to the commodified generic drug industry built on volume and speed, industry representatives said at the recent FDLI annual meeting.