FDA Law

JUNE 22, 2023

Most recently, Jeff Shuren, CDRH Director, gave a speech at the 2023 Food and Drug Law Institute (FDLI) annual conference in which he identified facilitating “availability of and access to existing and novel home-use medical technologies” as a strategic priority for 2022-2023 to advance health equity.

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FDA Law

MARCH 31, 2022

VBP pricing may be determined by outcomes-based measures, which substantially link a drug’s cost to its actual performance or a reduction in medical expenses, or by evidence-based measures, which substantially link cost to existing evidence of effectiveness and value for a specific use. See 42 C.F.R. 447.505(a), 85 Fed. 87000, 87102 (Dec.

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FDA Law

APRIL 11, 2022

As background, Medtronic manufactures the MiniMed 600 series insulin infusion pumps. Of course, it would not always be true that there is a significant gap between the number of medical devices shipped and the number in actual use. For instance, some products could remain in boxes in hospital inventory for an extended period.

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FDA Law

MAY 3, 2021

We thought this would be a good time to post a series of blog posts focusing on DEA inspections and how registrants should prepare for and manage them, with a list of registrant do’s and don’ts. The CSA establishes classifications for drugs based on their potential for abuse relative to their legitimate medical use. 21 U.S.C. §

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FDA Law

OCTOBER 10, 2022

The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains to Clinical Decision Support (CDS) software functions. Specifically, the guidance interprets the Cures Act’s four criteria for exclusion of CDS software functions from FDA’s medical device jurisdiction (so-called “Non-Device CDS”).

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FDA Law

JULY 5, 2023

Outsourcing facilities are not exempt from FDA’s cGMP for drug manufacturers (as lightly tweaked via cGMP Guidance for outsourcing facilities ) or adverse event reporting requirements , and are subject to regular inspection by FDA. Section II at 2. Draft Guidance III.B.2(e) Draft Guidance III.B.2(d)

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FDA Law

MARCH 6, 2025

Lenz, Principal Medical Device Regulation Expert & Lisa M. For non-AI-enabled devices, the early feasibility research may not directly affect the development process, i.e., the final, finished device can be fully developed, transferred to a controlled manufacturing environment, and tested under a design controls process.

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FDA Law

OCTOBER 17, 2023

Compared to the previous version, the new guidance document highlights that the Breakthrough Devices Program may also be applicable to certain devices that benefit populations impacted by health and/or healthcare disparities and to certain non-addictive medical products to treat pain or addiction. By Philip Won & Lisa M. 360e-3)).”

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FDA Law

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. MRAP would provide oversight of an accreditation body which would conduct assessments—paid for by the manufacturer—based on criteria developed by the MRAP. HHS would then use MRAP scores in the proposed Hospital Resilient Supply Program (HRSP).

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FDA Law

SEPTEMBER 28, 2022

Valley Hospital, Inc. 25, 2022), [link] , considered whether a provider’s use of a medical device that is the subject of an FDA safety communication constitutes per se evidence of wanton disregard, which would warrant punitive damages. Gonzalez & Jeffrey N. LEXIS 679 (NJ Aug.

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FDA Law

JANUARY 18, 2024

FDA found that marijuana continued to have a high potential for abuse, lacked accepted safety for use under medical supervision and had no currently accepted medical use in treatment in the United States. Schedule I drugs have a high potential for abuse and no currently accepted medical use in treatment in the U.S. 21 U.S.C. §

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FDA Law

MAY 21, 2024

The 2016 reviews concluded that marijuana continued to meet schedule I criteria for having a high potential for abuse, no currently accepted medical use in treatment in the U.S., and lacked accepted safety for use under medical supervision. Currently Accepted Medical Use in Treatment in the U.S. 21 U.S.C. § 21 U.S.C. §

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FDA Law

DECEMBER 14, 2023

Quoting a Pew Research poll, the governors expressed their “hope” that DEA reschedules cannabis to schedule III “this year” because 88% of Americans favor legalization for medical or recreational use. As explained more fully explained below, that impression would be partially correct, but partially incorrect. It will not.

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FDA Law

NOVEMBER 8, 2022

By Véronique Li, Senior Medical Device Regulation Expert — At the latest MedTech conference held in Boston, MA from October 24-26, we heard from FDA officials and industry representatives on a range of topics. Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF).

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