Pearl Pathways

As part of Versiti’s continued growth, we’re excited to announce the acquisition of Pearl Pathways, a trusted advisor and preferred partner for enabling innovative and expedited life science product development. bit.ly/3FPeLAc

This authorization marks an important step, not only in the fight against COVID-19, but also creating a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) pathway. wp.me/p8RFUE-1sv

Via @RAPSorg - FDA launches FAERS dashboard for COVID-19 therapies - bit.ly/3vscAMh #FDA #COVID19

"Pre-Clinical Pathways: Start Off On the Right Foot" - One of Pearl Pathways' Senior Advisors will speak during the Indiana Health Industry Forum (IHIF) Life Sciences Lunch webinar on Tuesday, March 16. Event info and registration: wp.me/p8RFUE-1s9

In response to the Covid-19 Public Health Emergency, the U.S. #FDA permanently exempted seven Class I device types from #510k premarket notification requirements. FDA also proposed similar exemptions for 83 Class II devices and one unclassified device. wp.me/p8RFUE-1ry

Pearl IRB Co-chair, Gretchen Parker, will be covering the 2020 Advancing Ethical Research Conference as part of the #AER20 Blog Squad! Tune in to the virtual conference over three weeks, Dec. 1-2, 8-9, and 15-16. bit.ly/3lxTDS9 @primrconnect

Pearl Pathways is speaking during the "Digital Health: Telemedicine and Virtual Clinical Trials" virtual conference, Nov 12-13. The event is part of the IU Center for the Business of Life Sciences Conference Series. See the full agenda here: bit.ly/3lql6WT #DigitalHealth

The riskier the study, the more rigorous the human subject protections required by the #IRB. Our IRB Chair discusses the different levels of risk and the several #regulations that must be considered when reviewing a study. wp.me/p92tF6-1XN

OHRP issues Guidance for application of the human subjects protection regulations to actions taken in response to the COVID-19 pandemic - lnkd.in/gPXtxzR

New blog: The simple, powerful question that drug and medical device developers should ask their #regulatory consultant - wp.me/p8RFUE-1oD

As organizations start to implement their response to the spread of COVID-19, it is likely that human subjects research will be affected. Read the Pearl IRB COVID-19 response on our blog: wp.me/p92tF6-1VY #COVID19 #humansubjects #clinicalresearch

“Some drug and device companies could run into problems as they seek Food and Drug Administration approval for their products after the agency moved to suspend inspections of foreign manufacturing plants through next month...” - bit.ly/2vY0xMX - via @medcitynews

@US_FDA launches new #PDUFA performance dashboards on FDA-TRACK. These dashboards reflect the most up-to-date data on the Agency's PDUFA performance, such as submissions received and actions taken. bit.ly/2VMrzRW

"Federal judge rules clinical trial sponsors must publish a decade’s worth of missing data" - bit.ly/2VEixq0 - via @statnews

FDA Speeds New Coronavirus Diagnostic Tests | #Regulatory Focus ift.tt/2I9ybld

Updated: Striking While the Iron is Hot: New NDA, BLA Filings Spike in Q1 of FY 2020 | #Regulatory Focus ift.tt/2SkmFbF

Pearl Pathways is looking forward to attending and speaking at the RAPS Euro Convergence this year in Brussels. #lifesciences #regulatoryaffairs #EUMDR

The Pearl team enjoyed some right-brain fun this afternoon for our company outing! 🎨

Day #2 of MD&M West is underway in beautiful Anaheim! Our team is looking forward to another full day of networking with life science and medical design/manufacturing professionals. #AdvMfgExpo

Drug-Drug Interactions: FDA Issues Guidance on Clinical, In Vitro Studies | #Regulatory Focus ift.tt/2TRkAWN