The purpose of the meeting is to solicit specific, actionable policy suggestions for the review staff of the FDA’s Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) regarding opportunities to promote effective drug development while maintaining the FDA’s regulatory standards for the assessment of safety and effectiveness of new drug products. Of interest are efforts that could be implemented in the near-term and that cut across multiple therapeutic areas.
This meeting is an opportunity for OND division leadership to receive input directly from the public, which is invited to provide input regarding:
- Areas where OND can provide additional guidance or prioritize additional scientific discussion to improve clarity and encourage effective drug development,
- Suggestions for guidance or policy development to facilitate drug development for diseases or conditions not currently amenable to targeted therapies,
- Advantages and disadvantages of extending novel trial designs to a wider range of therapeutic areas,
- Areas where further clarity of the FDA’s current thinking may be useful to address variability across divisions and
- Recommendations for how to promote effective drug development programs while managing the tension between innovation and the uncertainty it can introduce.
For more information on meeting logistics and to register please visit the meeting web page.
For those unable to attend the meeting, a docket (Docket Number FDA-2019-N-3453) will be open to collect comments.
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