Tag Archive: regulatory

Patient Safety is the Perspective for Prevention

April 3, 2024 || Cheryl Bondurant
 
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 asked the question why should we focus on regulatory inspection remediation instead of prevention of inspection remediation? For those of you who have been involved…

Remote Regulatory Assessments – Q&A: Here to Stay

February 9, 2024 || Emily Purchase
 
On January 26, 2024, the Food and Drug Administration (FDA) provided notification of a revised draft guidance on Remote Regulatory Assessments (RRAs).¬† The FDA has updated its guidance on remote regulatory assessments (RRAs), emphasizing that they differ from inspections and outlining new powers granted by a recent spending bill. The…

FDA Quality Management Maturity Program

January 15, 2024 || Martina McDonagh
 
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 patients. These shortages can be for a variety of factors including manufacturing and quality issues. To this end the FDA embarked on the Quality Management…