Electronics Information Manufacturing Specialization 
The Medical Futurist
JUNE 21, 2025
Compared to that, our hearing only processes 11 percent of information, while smell 3.5 Digital contact lenses sound like science fiction: the translucent layer on your eye transmitting special information about your body to an outside device. percent, touch 1.5 percent and taste 1 percent. Don’t you think that’s possible?
FDA Law Blog
NOVEMBER 20, 2024
Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting.
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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
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. Registrants should consult with counsel and their Human Resources departments in deciding whether to provide this information.
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. Registrants should consult with counsel and their Human Resources departments in deciding whether to provide this information.
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
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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