US FDA's Generic Research Projects Appear To Be Opening Way For ANDAs
Pre-ANDA meeting requests were high in some product categories where FDA conducted research projects, suggesting agency may influence sponsors' development priorities.
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With more than 1,600 pediatric and related clinical trials in house, the agency wants ideas for how they can be analyzed to advance pediatric drug development.
Biosimilar availability may not be in the its purview, but the FDA still is thinking about ways to help industry deal with the issue and support sector growth.
Both first-cycle approvals and priority assessment improvements have been the subject of questions and criticism as the FDA and industry attempt to boost generic competition.