TransPerfect Life Sciences’ Post

#R is taking over the regulatory submissions, with FDA allowing R-based submissions. Understand more about the wonders of #RProgramming and how it can be advantageous for your #clinicaltrials in our upcoming “R for Clinical Trials” webinar by R Guru Sunil Gupta on February 20. Haven’t registered yet? Do it today as only a few slots are left: https://bit.ly/49G7zDn #ClinicalResearch #Webinars #LifeSciences #Memes 

Do you have an Idea for a new drug, supplement or device? Are you wondering how to advance it into the clinic? We can help you navigate the regulatory and funding space. Our regulatory team can enable you to throw your hat into the ring by helping you develop a winning regulatory strategy, executing the strategy, writing grants and preparing for meetings and regulatory submissions at the FDA. #rarediseases #orphandrugs

FDA published new draft guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” (SIUU Guidance). In this article, our lawyers summarize how the new guidance clarifies longstanding questions about proactive dissemination of such information and might impact drug and device stakeholders. #healthcareproviders #HCPs #medicalproducts Meredith Manning, Heidi Gertner, Kristin Zielinski Duggan, Sally Gu

FDA published new draft guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” (SIUU Guidance). In this article, our lawyers summarize how the new guidance clarifies longstanding questions about proactive dissemination of such information and might impact drug and device stakeholders. #healthcareproviders #HCPs #medicalproducts

FDA published new draft guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” (SIUU Guidance). In this article, our lawyers summarize how the new guidance clarifies longstanding questions about proactive dissemination of such information and might impact drug and device stakeholders. #healthcareproviders #HCPs #medicalproducts

We analyze some of the key takeaways from FDA's new "SIUU" draft guidance in the article below. The draft guidance seems to raise as many questions as it answers, but nevertheless expands the types of communications that may be permissible. Much more to come on this... #pharmaceuticals #FDAguidance #regulatory

FDA published new draft guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” (SIUU Guidance). In this article, our lawyers summarize how the new guidance clarifies longstanding questions about proactive dissemination of such information and might impact drug and device stakeholders. #healthcareproviders #HCPs #medicalproducts

FDA published new draft guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” (SIUU Guidance). In this article, our lawyers summarize how the new guidance clarifies longstanding questions about proactive dissemination of such information and might impact drug and device stakeholders. #healthcareproviders #HCPs #medicalproducts

FDA published new draft guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” (SIUU Guidance). In this article, our lawyers summarize how the new guidance clarifies longstanding questions about proactive dissemination of such information and might impact drug and device stakeholders. #healthcareproviders #HCPs #medicalproducts

FDA published new draft guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” (SIUU Guidance). In this article, our lawyers summarize how the new guidance clarifies longstanding questions about proactive dissemination of such information and might impact drug and device stakeholders. #healthcareproviders #HCPs #medicalproducts