Tuesday, November 12, 2019

Tuesday, November 12, 2019

FDA held 10 drug application meetings in first 9 months of FY 2019

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.


FY 2019 Meetings on Drug and Biologics License Applications

Quarter HeldTitleDate HeldHeld as Required by Statute or Pursuant to Commitment Letter
Q1Patient-Focused Drug Development Guidance: Methods to Identify What Is Important to Patients and Select, Develop or Modify Fit-for-Purpose Clinical Outcome Assessments; Public WorkshopOct. 15, 2018Pursuant to Commitment Letter
Q1FDA Oncology Center of Excellence - Society for Immunotherapy of Cancer Public Workshop: Immunemodified Response Criteria in Cancer ImmunotherapyNov. 8, 2018N/A
Q1Quantitation of AAV-Based Gene Therapy ProductsDec. 7, 2018N/A
Q1Drug Development Tool Process Under the 21st Century Cures Act and Prescription Drug User Fee Act VI; Public MeetingDec. 11, 2018Pursuant to Commitment Letter
Q2US-Japan Cellular and Gene Therapy Conference March 7, 2019Other
Q2Enhancing the Incorporation of Patient Perspectives on Clinical Trials; Public Workshop March 18, 2019Pursuant to Commitment Letter
Q3Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards; Public Meeting April 10, 2019Pursuant to Commitment Letter
Q3Characterizing the Food and Drug Administration’s Approach to Benefit-Risk Assessment Throughout

the Medical Product Life Cycle; Public Meeting

May 16, 2019Pursuant to Commitment Letter
Q3Financial Transparency and Efficiency of the Prescription Drug User Fee Act; Biosimilar User Fee Act;

and Generic Drug User Fee Amendments; Public Meeting

June 7, 2019Pursuant to Commitment Letter
Q3Advancing the Development and Implementation of Analysis Data Standards: Key Challenges and Opportunities; Public MeetingJune 12, 2019Pursuant to Commitment Letter
Source: U.S. Food and Drug Administration

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