The Medical Futurist
JUNE 21, 2025
Although this revolution has been brewing for years, the past few months marked a major change , as algorithms finally moved out of the specialized labs and into our daily lives. The situation today is as follows: One company manufactures software for the radiology department which use a certain format of AI in their daily work.
The Medical Futurist
JUNE 21, 2025
Digital contact lenses sound like science fiction: the translucent layer on your eye transmitting special information about your body to an outside device. Harbisson received a specialised electronic eye, his “eyeborg” to be able to render perceived colours as sounds on the musical scale. Yet, it might be a reality soon.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
FDA Law Blog
SEPTEMBER 26, 2022
Brevig, Senior Regulatory Device and Biologics Exper — FDA recently published Alternative or Streamlined Mechanisms for Complying with the Current Good Manufacturing Practice Requirements for Combination Products; List under the 21st Century Cures Act in the Federal Register (FR Notice). By way of background, 21 C.F.R. § 21 C.F.R. §
FDA Law Blog
NOVEMBER 20, 2024
Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. FDA suggests that test articles represent the worst-case manufacturing process, and provide the examples that the device undergoes the greatest number of sterilization and/or reprocessing cycles.
FDA Law Blog
DECEMBER 3, 2023
As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028.
FDA Law Blog
MAY 20, 2021
At least two investigators must be present during the on-site inspection, but teams can include DEA special agents or task officers from state and local law enforcement and regulatory agencies. If the registrant has a manufacturing or import quota, the investigators may ensure the registrant has not exceeded their established quota.
FDA Law Blog
MAY 20, 2021
At least two investigators must be present during the on-site inspection, but teams can include DEA special agents or task officers from state and local law enforcement and regulatory agencies. If the registrant has a manufacturing or import quota, the investigators may ensure the registrant has not exceeded their established quota.
Expert insights. Personalized for you.
53 
Let's personalize your content