Public Meeting Seeks Priorities for New Drug Review

FDA says it is planning an 11/7 public meeting on “Promoting Effective Drug Development Programs: Opportunities and Priorities for FDA’s Office of New Drugs” to obtain “actionable policy suggestions“ for CDER review staff “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.” An FDA notice says CDER Office of New Drug leaders are interested in input on: 

• 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 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.