BOLDSCIENCE’s Post

LDTs, In house in vitro diagnostics under FDA..not only under the IVDR a new field!!! nice and clear article from Regulatory Affairs Professionals Society (RAPS) for better understanding!!

Accelerate your time-to-market for products treating serious conditions or unmet medical needs by understanding FDA Expedited Pathways ⏩ Access the infographic to learn about the six different FDA expedited programs and designations👇 🔷 The benefits 🔷 Qualifying criteria 🔷 Timing and procedures https://bit.ly/3UI13rm #FDA #FDAExpeditedPathways

Learning what information #raredisease patients & their care partners find helpful in their decision-making when considering #genetherapy is crucial to the FDA. Share your perspective at our 9/20 virtual listening meeting. Registration is free: https://bit.ly/3XUEQrP

Freyr brings you the latest Regulatory developments from US FDA, MDA, Swissmedic, EMA, MHRA, SFDA, EFSA, and more. Read through Freyr Regulatory Roundup and stay informed with the latest Regulatory updates from global Health Authorities. https://lnkd.in/gQ7u-7FF   #RegulatoryUpdates #HealthAuthorities #LifeSciences #FreyrSolutions #FreyrRegulatoryRoundup

FDA priority review date for MDMA-Assisted Therapy is Aug 11. It’s non-binding. Lots of us are holding our breath. It seems like we can expect 3 things to actually happen this week? 1) FDA publishes Approval Letter 2) FDA privately sends a Complete Response Letter to Lykos Typically sponsors will do their own press release or announcement but it’s up to them on when and how 3) FDA Extended review Seems like this is only in the case of new data or analysis that lead to a major amendment that requires additional time for review?

Have questions regarding SEND and its importance to your IND submission? Our expert Pete Gaskin provides a better understanding of the data framework and how it benefits your program’s submission to the FDA. Discover how our SEND team’s expertise can benefit your goal of getting your compound to the clinic. https://okt.to/CAFI5M

Btw, are you aware that there is no randomized placebo trial confirming that parachutes could save lives when jumping from a plane ? Would try it without one ??? “Conclusions As with many interventions intended to prevent ill health, the effectiveness of parachutes has not been subjected to rigorous evaluation by using randomised controlled trials. Advocates of evidence based medicine have criticised the adoption of interventions evaluated by using only observational data. We think that everyone might benefit if the most radical protagonists of evidence based medicine organised and participated in a double blind, randomised, placebo controlled, crossover trial of the parachute.” As a suggestion, I would recommend to all that believe what Peter McCullough and the McCullough Foundation to enroll in this trial. At least we have a 50% chance they might end up on no parachute arm… Irony… https://lnkd.in/er59TGHs

The latest CDE guideline offers advice on platform validation for viral clearance, with an approach that is consistent with the requirements of the ICH guideline Q5A(R2) and the region-specific guidance from the EMA and FDA. Find out more in our latest blog in the Regulatory Navigator series.

The latest CDE guideline offers advice on platform validation for viral clearance, with an approach that is consistent with the requirements of the ICH guideline Q5A(R2) and the region-specific guidance from the EMA and FDA. Find out more in our latest blog in the Regulatory Navigator series.

The latest CDE guideline offers advice on platform validation for viral clearance, with an approach that is consistent with the requirements of the ICH guideline Q5A(R2) and the region-specific guidance from the EMA and FDA. Find out more in our latest blog in the Regulatory Navigator series.