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PDUFA VI 2020 Public Meeting on Electronic Submissions and Data Standards

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Food and Drug Administration

10903 New Hampshire Ave

White Oak Campus, Building 31 Conference Center

Silver Spring, MD 20993

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DEPARTMENT OF HEALTH AND HUMAN SERVICE Food and Drug Administration Prescription Drug User Fee Act of 2017 Electronic Submissions and Data

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DEPARTMENT OF HEALTH AND HUMAN SERVICE

Food and Drug Administration

Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards; Public Meeting

AGENCY: Food and Drug Administration, HHS

ACTION: Notice of public meeting

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the following public meeting entitled “Prescription Drug User Fee Act of 2017 Electronic Submissions and Data Standards.” The purpose of the meeting is to fulfill its commitment to seek stakeholder input related to data standards and electronic submission system past performance, future targets, emerging industry needs and technology initiatives. FDA will use the information from the public meeting to provide input into data standards initiatives, the FDA IT Strategic Plan and electronic submissions gateway target timeframes.

DATE: The public meeting will be held on April 22, 2020, from 9 a.m. to 4 p.m.

ADDRESSES: The public meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503, Section A), Silver Spring, MD 20993-0002. Entrance for public meeting participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and securing information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm

FOR FURTHER INFORMATION CONTACT: Chenoa Conley, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1117, Silver Spring, MD 20993-0002, 301-796-0035, chenoa.conley@fda.hhs.gov, or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

I. Background

FDA is committed to achieve the long-term goal of improving the predictability and consistency of the electronic submission process and enhancing transparency and accountability of FDA information technology-related activities. In the PDUFA VI commitment letter, FDA agreed to hold annual public meetings to seek stakeholder input related to electronic submissions and data standards to inform the FDA IT Strategic Plan and published targets. The commitment letter outlines FDA’s performance goals and procedures under the PDUFA program for the years 2018 through 2022. The commitment letter can be found at https://www.fda.gov/forindustry/userfees/prescriptiondruguserfee/ucm446608.htm.

II. Participating at the Public Meeting

Registration: To register to attend “Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards,” Please visit the following website to register: https://www.eventbrite.com/e/pdufa-vi-public-meeting-on-electronic-submissions-and-data-standards-tickets-49895060469. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. A draft agenda will be posted approximately one month prior to the meeting.

Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public meeting must register by midnight on April 1, 2020, Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted.

Streaming Webcast of the public meeting: This public meeting will also be held via Adobe Connect webcast. https://collaboration.fda.gov/pdufa042220/

As a reminder, the public meeting begins at 9am. Due to parking constraints, it’s advisable to arrive by 8 am, for the FDA White Oak shuttle transportation. The entrance for the public meeting participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information, please refer to: https://www.fda.gov/about-fda/white-oak-campus-information/public-meetings-fda-white-oak-campus

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Food and Drug Administration

10903 New Hampshire Ave

White Oak Campus, Building 31 Conference Center

Silver Spring, MD 20993

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