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The Economics of Investigational Device Exemption (IDE) Studies: What You Need to Know About Medicare Coverage

The Premier Consulting Blog

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]

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Article FDA Thank You FDA updates set the stage for broader use of harmonized standards for safety reporting

Agency IQ

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. That revised version remains in use today ( more on this below ).

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Article EMA Thank You The devil is in the details: a deep dive into the state of Notified Body designations

Agency IQ

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). 23 MDS 1003 Devices manufactured utilising tissues or cells of animal origin, or their derivatives Section 5.3.2

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CHMP positive opinion recommending approval of Benlysta for adult patients with active lupus nephritis

The Pharma Data

Active LN was confirmed by renal biopsy during screening visit using the 2003 International Society of Nephrology/Renal Pathology Society criteria within the past 6 months, and clinically active kidney disease requiring induction therapy. [1]. About lupus nephritis.

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Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Agency IQ

Within the realm of FDA-required labeling, there are currently a few different types of information a sponsor might develop specifically for patient use: medication guides, instructions for use (IFU), consumer medical information (CMI) and patient package inserts (PPI).

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European Commission approves Benlysta for adult patients with active lupus nephritis

The Pharma Data

Active LN was confirmed by renal biopsy during screening visit using the 2003 International Society of Nephrology/Renal Pathology Society criteria within the past 6 months, and clinically active kidney disease requiring induction therapy. [1]. Premedication: An antihistamine, with/without an antipyretic, may be administered.

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Transitioning to eCTD v4.0

The Premier Consulting Blog

In 2003, the original eCTD was adopted by health authorities and sponsors both in the U.S. Sponsors should prepare by reviewing implementation packages from the ICH and applicable regions. Implementation Package v1.5 Implementation Package v1.5 Module 1 Implementation Package FDA eCTD v4.0 How can you prepare?