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The Medical Futurist
JUNE 21, 2025
Large language models will soon find their way in to everyday clinical settings , simply because the global shortage of healthcare personnel is becoming dire and AI will lend a hand with tasks that do not require skilled medical professionals. This potential is very important because such a breakthrough won’t come about in any other way.
FDA Law Blog
FEBRUARY 9, 2024
Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. The guidance addresses the use of DHTs in clinical investigations of drugs, biologics, and medical devices.
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FDA Law Blog
MARCH 8, 2023
By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time.
FDA Law Blog
SEPTEMBER 27, 2023
The issues appropriate for an INTERACT meeting typically relate to IND requirements, such as questions about IND-enabling studies, complex manufacturing technologies or processes, development of innovative devices used with a drug or biologic, or the use of New Approach Methodologies (methods to be used in place of traditional animal testing).
FDA Law Blog
JULY 7, 2024
Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.
FDA Law Blog
JANUARY 8, 2023
The Act mandates that DEA streamline and accelerate registration application procedures for cannabis researchers and manufacturers of cannabis for research. If a researcher wishes to change those research elements, they must notify DEA via registered mail or electronically within 30 days before implementation. Application Process.
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