USFDA BIMO Report presentation issued

The presentation gives an overview on the 2017 inspections and findings

These slides provide annual inspection metrics for the compliance programs overseen by the Office of Scientific Investigations (OSI) and the Office of Study Integrity and Surveillance (OSIS) in FDA’s Center for Drug Evaluation and Research (CDER). The vast majority of these inspections are conducted by FDA’s Office of Regulatory Affairs (ORA).

As FDA’s approval decisions are based on a review of the data submitted by an applicant, it is essential to ensure the integrity of the data submitted and to verify that the rights, health and welfare of those who participated in the studies were protected and that applicants continue to meet their obligations (e.g., for safety reporting) after approval. On-site inspection is one of many tools the FDA has for ensuring the integrity of data, the health and welfare of research participants, and the protection of public health.

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