The U.S. Food and Drug Administration held 10 public meetings related to the review of license applications for drugs and biologics during the first three quarters of fiscal-year 2019, the regulatory agency reported last month.
The FDA releases information about such meetings to comply with the reporting requirements of the FDA Reauthorization Act of 2017.
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FY 2019 Meetings on Drug and Biologics License Applications
| Quarter Held | Title | Date Held | Held as Required by Statute or Pursuant to Commitment Letter |
| Q1 | Patient-Focused Drug Development Guidance: Methods to Identify What Is Important to Patients and Select, Develop or Modify Fit-for-Purpose Clinical Outcome Assessments; Public Workshop | Oct. 15, 2018 | Pursuant to Commitment Letter |
| Q1 | FDA Oncology Center of Excellence - Society for Immunotherapy of Cancer Public Workshop: Immunemodified Response Criteria in Cancer Immunotherapy | Nov. 8, 2018 | N/A |
| Q1 | Quantitation of AAV-Based Gene Therapy Products | Dec. 7, 2018 | N/A |
| Q1 | Drug Development Tool Process Under the 21st Century Cures Act and Prescription Drug User Fee Act VI; Public Meeting | Dec. 11, 2018 | Pursuant to Commitment Letter |
| Q2 | US-Japan Cellular and Gene Therapy Conference | March 7, 2019 | Other |
| Q2 | Enhancing the Incorporation of Patient Perspectives on Clinical Trials; Public Workshop | March 18, 2019 | Pursuant to Commitment Letter |
| Q3 | Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards; Public Meeting | April 10, 2019 | Pursuant to Commitment Letter |
| Q3 | Characterizing the Food and Drug Administration’s Approach to Benefit-Risk Assessment Throughout
the Medical Product Life Cycle; Public Meeting | May 16, 2019 | Pursuant to Commitment Letter |
| Q3 | Financial Transparency and Efficiency of the Prescription Drug User Fee Act; Biosimilar User Fee Act;
and Generic Drug User Fee Amendments; Public Meeting | June 7, 2019 | Pursuant to Commitment Letter |
| Q3 | Advancing the Development and Implementation of Analysis Data Standards: Key Challenges and Opportunities; Public Meeting | June 12, 2019 | Pursuant to Commitment Letter |
