Invitation to attend public workshop on Generic Drug Regulatory Science Initiatives and public meeting on Electronic Submissions and Data Standards

FY 2018 Generic Drug Regulatory Science Initiatives Public Workshop The Food and Drug Administration (FDA) is hosting the FY 2018 Generic Drug Research Public Workshop to give an overview of the status of regulatory science initiatives for generic drugs. We want your input as we develop an annual list of regulatory science initiatives specific to generic drugs. We will take the information obtained from the public workshop into account in developing our fiscal year 2019 regulatory science initiatives. Participate The meeting will be held at FDA’s main campus in Silver Spring, Maryland, on May 24, 2018, from 8:30 a.m.–4:30 p.m.and will be webcast for those who cannot attend in person. Please submit requests to make oral presentations during your online registration by April 24, 2018. You may also suggest generic drug research topics that should be added to the fiscal year 2019 regulatory science initiatives by sending an email to GDUFARegulatoryScience@fda.hhs.gov. Notify Us If you wish to attend in person or via webcast, please email GDUFARegulatoryScience@fda.hhs.gov by April 24, 2018. The email should contain complete contact information for each attendee (i.e., name, title, affiliation, address, email address, telephone number, and whether you will be attending in person or by webcast). Those without email access can register by contacting Stephanie Choi (Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4736, Silver Spring, MD 20993, 240-402-7960) by April 24, 2018. If you need special accommodations because of a disability, please contact Stephanie Choi no later than April 24, 2018. Electronic Submissions and Data Standards Public Meeting The FDA has announced a public meeting entitled “Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.'' The topics to be discussed include the current status of electronic submissions and data standards initiatives to improve the predictability and consistency of the electronic submissions process in support of the human drug review program. FDA is seeking input from a variety of stakeholders—industry, academia, patient advocates, professional societies and other interested parties—as it fulfills its commitment under the Prescription Drug User Fee Act of 2017 (PDUFA) to hold annual public meetings to seek stakeholder input related to enhancing the transparency and accountability of the electronic submission and data standards activities. FDA will use the information from the public meeting to inform the development of the FDA Information Technology (FDA IT) Strategic Plan and electronic submissions gateway target timeframes. Registration closes on February 19th. To register, send an email to cderdatastandards@fda.hhs.gov.