Top Tweets for #InvestigationalTesting
Fantastic engagement on #RegulatoryMedtech2021 Day 1 topic of #ClinicalTrial pilot inspections for #MedicalDevice #InvestigationalTesting! Insightful #Regulatory questions to the #HealthCanada inspectors just kept coming! When posted, it's worth rewatching! #MedTech #MDIT #ITA :)
LAST CHANCE! Register for Canada’s Regulatory Medtech Conference 2021, June 2 & 9 AND Oct 20 & 21, participate in live & on-demand sessions, multiple networking opportunities, connect with Health Canada #RegulatoryMedtech2021 #RegulatoryAffairs #medtech https://t.co/qJhsQLvp0u
The same applies to #HealthCanada (@GovCanHealth). Commercial licensing is an approval -- broadly scoped, i.e. population. #SpecialAccess, #InvestigationalTesting, or #ExpandedUse are authorizations -- narrowly scoped, i.e. specific patient(s). #Regulatory https://t.co/B0GuOS6Y5C
“We were clear that an Emergency Use Authorization is not an FDA approval in any shape or form” for hydroxychloroquine, top FDA official Janet Woodcock tells @pharmalot in an interview.
https://t.co/DgHEy9RgTw
Although I appreciate (and have/will benefit) #ClinicalResearch, #ClinicalTrials, or #InvestigationalTesting, it raises #regulatory & potential ethical concerns. I sincerely hope that existing #ICF (informed consent forms) will aid patients to objectively decide. #MedicalDevice https://t.co/FsAoRaqisN
Considering the ever-evolving world of Software as #MedicalDevice (#SaMD) or cloud-based #MedDevice Software as a Service (#SaaS), I'm curious if one day the industry (with #regulatory consensus) would roll out future #InvestigationalTesting akin to #BetaTesting today. Thoughts?
Odds are that if you're supporting novel & innovative #MedTech #Regulatory, you also file for #InvestigationalTesting Authorizations (#ClinicalTrials). ICYMI @GovCanHealth is consulting on its new #ITA guidance, so let #HealthCanada know by Feb 16, 2018! https://t.co/lTS1RawW2e
@GovCanHealth @HealthCanada Among other needed updates and #Regulatory clarifications, @GovCanHealth's #InvestigationalTesting Authorizations #ITA flowchart in Appendix 3 is a helpful overview of when a #MedicalDevice #ITA is req'd in #Canada. Also, Appendix 5 with #FAQ section clarifying #REB & #OffLabel.
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