Zara Schaffer

Hi, on the FDA’s own website re de novo applications, I see that the decision times are usually around 120 days or, if they go over, 150 days in which the FDA would inform the applicant what issues are causing the delay: https://www.fda.gov/media/107652/download However, with some companies, for example, INVO Bioscience’s de novo application for its INVOcell, it took way longer than 150 days (the application was sent on Feb 23, 2015 and the decision came on November 2, 2015). My question is this: what are the July 1, 2015 and July 6, 2015 dates in the November 2, 2015 decision letter the FDA sent to INVOcell? There’s no mention of these dates anywhere else in the letter, and it’s not the submission date (that would be Feb 23, 2015). https://www.accessdata.fda.gov/cdrh_docs/pdf15/den150008.pdf Does anyone know? I’m just trying to figure out how de novo timelines work. Thank you!

Hi, I’m trying to find a reliable timeline for FDA’s Emergency Use Authorizations (EUA’s). With FDA’s BLA and NDA applications, it’s 10 months or 6 months with Priority Review. But I can’t find anything on EUA’s except for a very general “it can be fast” timeline found on the FDA website (and I know some EUA’s that have taken months, though only like around 3, which is even shorter than Priority Reviews): “FDA is prepared to issue EUAs expeditiously (e.g., within hours or days) when circumstances warrant and adequate information has been made available for prior review through pre-EUA interactions.” https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities So does anyone know timeline/deadline for FDA’s EUA’s—or at least within what period most EUA’s fall into (before 3 months, before 2 months, etc.)?

I have a question re FDA’s approval process for Investigational Device Exemption (IDE). On the FDA website, it says it’ll take 30 days or less to approve an IDE application: “An IDE application is considered approved 30 days after it has been received by the FDA, unless the FDA otherwise informs the sponsor via email prior to 30 calendar days from the date of receipt, that the IDE is approved, approved with conditions, or disapproved.” https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-approval-process However, with some companies, I noticed it takes far longer than 30 days. For example, Check-Cap submitted an IDE application on Oct 9, 2018, but it didn’t receive approval until Dec 13, 2018, which is far longer than 30 day https://www.prnewswire.com/news-releases/check-cap-announces-ide-submission-to-fda-for-its-c-scan-system-300727577.html https://www.prnewswire.com/news-releases/check-cap-announces-fda-conditional-approval-of-ide-to-initiate-us-pilot-study-of-c-scan-300764947.html Why is this? Is this considered normal? Wouldn’t FDA be in violation of its own timeline rules? Please help. I’m trying to figure this out.