@PearlPathways

A life science company dedicated to accelerating drug and device development. Your trusted advisor in regulatory, GXP quality, auditing, clinical, IRB services

 Indianapolis, IN
pearlpathways.com
Joined January 2016
  • Tweets1.2K
  • Following765
  • Followers432
363Media
Pearl Pathways retweeted
Versiti@Versiti7 Nov 2023
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
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FDA Speeds New Coronavirus Diagnostic Tests | #Regulatory Focus ift.tt/2I9ybld
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Updated: Striking While the Iron is Hot: New NDA, BLA Filings Spike in Q1 of FY 2020 | #Regulatory Focus ift.tt/2SkmFbF
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Drug-Drug Interactions: FDA Issues Guidance on Clinical, In Vitro Studies | #Regulatory Focus ift.tt/2TRkAWN
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European Parliament Adopts Second Round of MDR, IVDR Corrigenda | #Regulatory Focus ift.tt/2sAS4NP
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European Parliament Signs Off on Second Round of MDR, IVDR Corrigenda | #Regulatory Focus ift.tt/2Yd70gy
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Orphan Drug Recall Leaves Patients in the Lurch | #Regulatory Focus ift.tt/34If0Zc
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The new EU MDR and its impact on drug device combination products | #Regulatory Focus ift.tt/2WxmYBG
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Trump Nominates Hahn to be FDA Commissioner | #Regulatory Focus ift.tt/2Nvv89j
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Pearl Pathways retweeted
MedTech Dive@MedTechDive10 Oct 2019
The designation gives in vitro diagnostic makers their first available notified body under #IVDR. So far, five notified bodies have been designated under #MDR. bit.ly/33huK4A
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.@US_FDA’s Woodcock Weighs in on Role of @NIH in Drug Development | #Regulatory Focus bit.ly/2OgX3gZ #pharma
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Takeaway from the OHRP-led session on "What's New in Informed Consent" - The Common Rule is the legal floor for what is necessary for human subjects protection. However, ethical reasons may prompt a researcher to do more than the minimum. @nwabr
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The @nwabr 2019 Research Community Forum and IRB Conference is underway! Leaders from #OHRP will lead today's workshops.
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RAPS Publishes Updated Fundamentals of US #RegulatoryAffairs Book | #Regulatory Focus bit.ly/2XOlqqK #pharma #medtech #biotech
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Estimated 41,760 people will die from #breastcancer this year. @ndideacenter's #NearWave safe tissue #imaging technology can improve survival by predicting therapy response in 2 weeks giving ability to change therapy plans if not working & reduce time to surgery
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.@US_FDA Chief of Staff to Step Down This Month | #Regulatory Focus bit.ly/2QJ2Mda #FDA
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.@US_FDA Replaces Withdrawn Biosimilar Guidance With New One on Quality-Related Considerations | #Regulatory Focus bit.ly/2w8xa7d #FDA #biosimilars
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Reassessing Benefit-Risk: @US_FDA Preps for New Guidance | #Regulatory Focus bit.ly/2WMSVVD #FDA
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Woodcock Details Upcoming Changes to NDA and BLA Review Process | #Regulatory Focus bit.ly/2Y8pn5n #FDA #regulation #pharma #biotech
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.@FDACommissioner Sharpless Begins to Learn the Ropes While @US_FDA Center Directors Look to the Future | #Regulatory Focus bit.ly/2VED7al #FDA #FDLI19 @reaganudall
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