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BioCommunique Article

The public meeting solicited policy suggestions that could be implemented by the review staff to promote effective drug development.

CDER’s Office of New Drugs Considers Stakeholders’ Policy Recommendations

  • 2019-11-14T02:16:00.000+0000
  • Washington DC
  • Author: Brittany Blocker

On November 7, the Center for Drug Evaluation and Research’s (CDER) Office of New Drugs (OND) held a public meeting to solicit specific, and actionable policy suggestions that could be implemented in the near-term by the review staff to promote effective drug development without compromising regulatory standards for safety and efficacy.

The OND division leadership is interested in input about where OND can provide additional guidance or prioritize additional scientific discussion in the near-term to improve clarity and encourage effective drug development. They are also seeking suggestions for guidance or policy development that OND could undertake to facilitate drug development for diseases not currently amenable to targeted therapies. Additionally, stakeholders were asked to share views on the advantages and disadvantages to extending novel trial designs to additional therapeutic areas and what guidance development would be useful. OND also requested feedback on guidance that needs further clarification and how OND can promote effective drug development programs.

The panel heard presentations from over twenty companies, industry, and patient organizations. A common recommendation was to improve transparency. Commenters also recommended that the FDA should consider opportunities for greater engagement in developing priorities for guidance development and revision similar to CDRH’s annual approach for seeking stakeholder input on guidance document development.

The Biotechnology Innovation Organization (BIO) proposed new guidance on coordination across FDA review divisions and the Centers on Digital Technologies including the use of siteless trials, digital endpoints, combination products that contain a digital component, and digital technologies used to support patient adherence and pharmacovigilance. BIO also suggested new guidance to provide clarity on alternative preclinical tools/non-animal methods and clarity to sponsors developing analgesics. To further advance the use and acceptance of innovative clinical trial design, BIO asked the agency to provide clarity on study conduct and data integrity when using a master protocol, adequate evidence for decision making, suitable interventional and control arms, and sufficient safety monitoring and comparisons.