The Medical Futurist
JUNE 21, 2025
Their research showed promising results for lab rats, and they plan to carry out the first human trials in the second half of 2017 and gather preliminary results during 2018. Digital contact lenses sound like science fiction: the translucent layer on your eye transmitting special information about your body to an outside device.
FDA Law Blog
SEPTEMBER 26, 2022
FDA published a proposed list on June 13, 2018 (83 FR 27609), which we blogged about here. The list of alternative mechanisms for complying with Part 211 in this FR Notice is not different from what was proposed in the 2018 FR Notice. or that FDA proposes can satisfy the requirements in § 4.4 much like an FDA guidance document.
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FDA Law Blog
NOVEMBER 20, 2024
of ISO 10993-1:2018, but is extremely burdensome and not referenced in the related ISO 10993-18. It is recommended to submit a Pre-Submission to the Agency when considering your chemical characterization strategy, especially for any devices/materials with special considerations or use of alternative strategies and solvents.
Annals of Family Medicine
NOVEMBER 20, 2024
Setting/Dataset Data were extracted from the electronic health records at a Family Medicine practice in Philadelphia, PA. Population Studied Inclusion criteria were ages 16-45 with a DME performed between 2018 and 2023. Special attention must be paid to the gaps in care and the risk of infectious diseases in this population.
FDA Law Blog
JULY 10, 2023
Understanding the Traditional 510(k) Review Timeline There are three types of Premarket Notification 510(k)s: Traditional , Special , and Abbreviated. Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 Average Number of Industry Days to MDUFA IV Decision 54.69
GeriPal
SEPTEMBER 7, 2023
William: So ASCO decided to make a high priority this year to redo the guidelines, which were originally released in 2018. So I make the point, they often say, “Oh, you have this special population,” like pediatrics, where it’s 10% or something. Or electronically, to fill out, right? Do you worry about that?
FDA Law Blog
JUNE 10, 2025
DEA publishes the Special Surveillance List to inform about potential illicit uses of a laboratory supply and reminds that civil penalties may be imposed on businesses that distribute a laboratory supply with reckless disregard for the illegal uses to which it will be put. DEA published the original Special Surveillance in May 1999.
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