2016 Clinic Management Manufacturing 
FDA Law Blog
OCTOBER 10, 2022
Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Other medical information.
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 simulated use/leachables studies to simulate the clinical use (i.e., Many sponsors want to reduce animal testing and, therefore, welcome the approach.
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FDA Law Blog
FEBRUARY 22, 2023
In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. Consider this scenario: A manufacturer files a 510(k) for a Class II device, a surgical mask.
FDA Law Blog
MAY 5, 2024
The White House Office of Management and Budget will review the rescheduling proposal. FDA/HHS Analysis, 2023 FDA/HHS last conducted an eight-factor analysis of marijuana in 2016 and concluded that marijuana continued to meet schedule I criteria. 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed.
FDA Law Blog
NOVEMBER 8, 2022
Fellow panelist, August Bencke Geyer, who serves as Deputy General Manager of the Medical Devices Office at ANVISA (Brazilian Health Regulatory Agency) expressed enthusiasm and indicated that Brazilian regulators are watching closely to see how the program unfolds. It’s an easy way to manage the transition.”.
FDA Law Blog
SEPTEMBER 13, 2021
A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.
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