by Jordann Rufo | Nov 14, 2024 | News
510(k) Submissions Can Be RejectedWhy do approximately 30% of medical device 510(k) submissions fail* initial review? After spending extensive time and resources on a 510(k) submission, the worst news a team can receive is that their application has failed....
by Jordann Rufo | Sep 3, 2024 | News, Uncategorized
Look-alike medication labels is one of the most frequently reported issues with injectable products reported to the Institute for Safe Medication Practices (ISMP), Med Safety Board’s parent organization. This continued evidence of mix-ups between look-alike products,...
by Michael Kelly | Oct 3, 2023 | News
Becky Lamis, PharmD, FISMPManager, Med Safety Board (MSB) While 503B outsourcing facilities must meet current good manufacturing practice requirements, they are not subjected to the same labeling and packaging safety standards and review process as recommended or...
by Jordann Rufo | Jun 15, 2023 | News
Becky Lamis, PharmD, FISMPManager, Med Safety Board The Institute for Safe Medication Practices (ISMP) received a safety concern from clinicians through its national error reporting program regarding the packaging of an enteral/oral probiotic. ISMP, which is Med...
by Jordann Rufo | May 25, 2023 | News
The US Food & Drug Administration (FDA) will host its annual Regulatory Education for Industry (REdI) Conference as a virtual no-cost event, June 5-9. This is an excellent learning opportunity for industry professionals to hear directly from FDA’s experts in...
by Jordann Rufo | May 18, 2023 | News
Becky Lamis, PharmD, FISMPManager, Med Safety Board Earlier this year, Med Safety Board’s parent organization and ECRI-affiliate, the Institute for Safe Medication Practices (ISMP), published an article entitled, Latent and active failures perfectly align to allow a...
