News & Events
The Impact of Human Factors Engineering Studies on 510(k) Success
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....
Med Safety Board Releases White Paper Emphasizing that Injectable Medication Labels Must Be Well-Differentiated to Prevent Patient Harm
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,...
Preventing cisplatin-induced ototoxicity in pediatrics – Join us for a free webinar on March 5 to learn how to reduce risk and improve patient outcomes
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...
Patient Safety Issues with 503B Labeling and Packaging: Making the Case for Outsourcers to Follow FDA Guidance
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...
How Misleading Packaging Can Result in Wrong-Route Errors
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...
FDA hosts annual virtual event: Regulatory Education for Industry (REdI) Annual Conference, June 5-9, focused on drugs, devices and biologics
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...
Similar IV Bag Labels Can Lead to Error
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...
Med Safety Board to present webinar with Regulatory Affairs Professional Society (RAPS) on FDA’s current guidance on safe medication container labeling
In a free webinar on March 14 at 12 pm ET hosted by Regulatory Affairs Professional Society (RAPS), Med Safety Board experts will review the significant changes in the finalized FDA guidance: "Safety Considerations for Container Labels and Carton Labeling Design to...
Learn what’s new in FDA’s finalized guidance for industry – join us for a free webinar on September 15
On September 15 at 12 pm ET, Med Safety Board experts will review the significant changes that were incorporated into the finalized FDA guidance: Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors in a free webinar. The...
FDA finalizes guidance on safety considerations for container and carton labeling
On May 18, the US Food and Drug Administration (FDA) posted the finalized guidance for industry Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors. This guidance document represents FDA’s current thinking on safe...