Medmarc Blog (blog.medmarc.com)
Posts about
Risk Management (2)
FDA Releases Draft Guidance for Remote Regulatory Assessments
September
13,
2022
The FDA has released a draft guidance for its use of remote regulatory assessments (RRAs), which is an outgrowth of the virtual inspections the agency conducted during the COVID-19 pandemic. These...
Comment Period Closes for FDA’s Draft Guidance Document, "Risk Management Plans to Mitigate the Potential for Drug Shortages"
August
09,
2022
The COVID-19 pandemic brought to light the fragility of the pharmaceutical supply chain and demonstrated that disruptions can lead to drug shortages. We have written extensively about the...
Semiconductor Shortage Still a Concern for Device Makers
July
25,
2022
The shortage of semiconductors continues to present problems to the medical device industry, a critical issue for patients in need of devices that are largely or entirely dependent on these products....