PDUFA VI: Fiscal Years 2018 - 2022 | FDA

PDUFA VI: Fiscal Years 2018 - 2022 | FDA

FDA Announces Public Meeting on Independent Assessment of Communications Between FDA and Sponsors During Drug Development

On August 11, 2020, the U.S. Food and Drug Administration (FDA) will hold a public meeting to discuss Eastern Research Group, Inc.’s (ERG) assessment of communication practices between FDA and sponsors during the investigational new drug (IND) phase of new drug/biologic development. Completion of the assessment and the public meeting satisfies FDA’s commitment to use an independent third party to assess FDA-sponsor communication practices during the IND stage of drug/biologic development, mandated by the Prescription Drug User Fee Act for fiscal years 2018 through 2022 (“PDUFA VI”). The purpose of this public meeting is to share ERG’s assessment of FDA-sponsor communications, which used information from Agency databases, meeting observations, and feedback from both FDA and sponsors to examine current best practices, major challenges, and recommendations for improvement. The public meeting will consist of ERG’s presentation of their assessment, presentations by invited regulatory and industry representatives, a panel discussion, and an open public comment period. Following presentation and discussion of ERG’s assessment and public comments, FDA will consider the results, findings, and recommendations to determine what, if any, refinements in IND stage communication practices are warranted. For additional information about this public meeting and to register to attend, please visit FDA’s website by August 4, 2020. The meeting’s agenda, additional materials, and any changes to the meeting location or webcast information will also be available on the website. Public comments will also be accepted until September 11, 2020 by submission to Docket No.: FDA-2020-N-1529.