regulatory Archives

Blog Post

Patient Safety is the Perspective for Prevention

When I first started writing this blog, the subject was remediation for regulatory inspections. But, as I progressed through the authoring of this blog, I...

Remote Regulatory Assessments – Q&A: Here to Stay

On January 26, 2024, the Food and Drug Administration (FDA) provided notification of a revised draft guidance on Remote Regulatory Assessments (RRAs). The FDA has...

FDA Quality Management Maturity Program

Drug shortages in the pharmaceutical industry is a significant concern that has far-reaching consequences for the industry, the regulators, the healthcare system, and ultimately the...