The Premier Consulting Blog

DECEMBER 28, 2023

3] Understanding Medicare Coverage for IDE Studies The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) allows for Medicare coverage of the routine costs of care provided to Medicare beneficiaries in certain categories of Investigational Device Exemption (IDE) studies. [4] 5] US Food and Drug Administration.

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The Pharma Data

MARCH 26, 2021

This CHMP opinion follows the recent label expansion by the US Food and Drug Administration to include LN. It causes inflammation in the kidneys and can lead to end-stage kidney disease which may require dialysis or a transplant. 2] LN can lead to end-stage kidney disease, which requires kidney dialysis or a transplant.

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Agency IQ

APRIL 8, 2024

When the document was taken back to the drawing board again in 2003, it remained on hold for more than a decade until a final version was agreed upon in 2012, with the FDA officially adopting it in 2014. While the SRP could be used to submit information on drugs and biological products, the only exception was for vaccines.

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Agency IQ

JUNE 7, 2024

The directives also had special scopes describing, for example, devices incorporating drugs, IVDs and medical devices in sterile condition, etc. There are two codes that all 49 Notified Bodies received designation to – devices with a measuring function (MDS 1010) and devices that require packaging/labeling (MDT 2011).

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Agency IQ

JUNE 16, 2023

The Iron and Steel Manufacturing Facilities NESHAP was promulgated pursuant to section 112(d) of the Clean Air Act (CAA) on May 20, 2003, and subsequently amended on July 13, 2006. See Asbestos Disease Awareness Organization v. This action will address Louisiana Environmental Action Network v. 19-CV-00871; State of California et al.

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Drug & Device Law

JANUARY 4, 2024

2003); Birdsong v. Under the Act a “qualified countermeasure” includes any “biological product” (what vaccines are) used “to diagnose, mitigate, prevent, or treat harm from any biological agent (including organisms that cause an infectious disease).” See Henry Schein, Inc. Stromboe , 102 S.W.3d 3d 675, 698 (Tex. Ogle , 108 S.W.3d

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