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The FDA has revised a previous draft on its current approach to conducting remote regulatory assessments (RRA), incorporating public comments as well as recent amendments to the Food, Drug and Cosmetic Act. Read More
Inspections will be much more streamlined once the FDA completes its sweeping reorganization, according to Deputy Commissioner Janet Woodcock. Read More
After 19 pilot programs conducted with medical device companies, regulators and patient communities, CDRH’s revised CAPA process is showing a 60 percent closure rate in under 60 days and a 50 percent overall reduction in improvement timelines, say FDA officials. Read More
The COVID-19 public health emergency may be officially over, but the temporary changes it provoked in regulatory assessments are here to stay, experts said during the 18th Annual FDA Inspections Summit last week. Read More
Many pre-approval inspections that were in limbo because of the backlog during the pandemic are now going ahead and the uptick could result in more product approvals, according to regulatory attorney Cathy Burgess, a partner in the law firm Alston & Bird. Read More
While it might seem obvious, achieving effective corrective and preventive action (CAPA) plans requires diligence and consistent application of three core elements. Read More
A critical component of any strong quality management system (QMS) for manufacturing FDA-regulated medical products is the presence of a structured approach to investigating root causes of product and process shortcomings, and then taking action to address the root cause(s) through the corrective and preventive action (CAPA) process. Read More
The former CEO of Utah-based device maker Dolor Technologies will be sentenced Nov. 8 on misdemeanor charges related to failure to seek FDA approval for a device to treat migraine headaches. Read More