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 Jordann Rufo | Feb 13, 2024 | Event
On March 5 at 2 pm ET, Med Safety Board (MSB), a subsidiary of the Institute for Safe Medication Practices (ISMP), will host an educational program in which expert faculty will review therapy considerations for reducing the risk of cisplatin-induced ototoxicity in...
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...
