FDA: Proposed Rule: Reporting Information Regarding Falsification of Data

BIO supports FDA’s stated goals of protecting the rights, safety and welfare of research subjects and of assuring the validity of data that the Agency receives in support of product approvals and for other purposes. BIO has concerns, however, regarding the broad and vague nature of the proposed rule, the lack of a threshold for reporting possible falsification of data, and the practical impact of the timing of reporting proposed by the Agency.