The Medical Futurist
JUNE 21, 2025
Finally, the arrival of interoperability can connect and harmonise various hospital systems An M-LLM could serve as a central hub that facilitates access to various unimodal AIs used in the hospital, such as radiology software, insurance handling software, Electronic Medical Records (EMR), etc.
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.
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FDA Law Blog
FEBRUARY 9, 2024
Drug or biologic sponsors should engage with manufacturers of DHTs to ensure appropriate evidence has been established for the DHTs before use in a clinical study. However, in general, FDA does not intend to request machine or raw data that require electronic processing to be understood in an inspection.
FDA Law Blog
JULY 20, 2021
FTC received more than 700 comments in response to the notice of proposed rulemaking from individuals, industry groups, consumer organizations, and members of Congress. listing “made,” “manufactured,” “built,” “produced,” “created,” or “crafted” in the United States or in America). The final rule was published on July 14, 2021.
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
MAY 20, 2021
Registrants must account for all of the controlled substances they receive, manufacture, or otherwise handle, so it is important that registrants document all controlled substance movement from receipt to transfer from the facility or disposal. Accountability Audit. They also review CSOS transactions for completeness and accuracy.
FDA Law Blog
MAY 20, 2021
Registrants must account for all of the controlled substances they receive, manufacture, or otherwise handle, so it is important that registrants document all controlled substance movement from receipt to transfer from the facility or disposal. Accountability Audit. They also review CSOS transactions for completeness and accuracy.
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