The Premier Consulting Blog

DECEMBER 28, 2023

Charging for Investigational Devices in IDE Studies Under IDE regulations, sponsors are allowed to charge for an investigational device provided that the charge does not exceed an amount necessary to recover the costs of manufacture, research, development and handling of the device. [2]

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The Pharma Data

MARCH 26, 2021

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. GSK’s commitment to immunology.

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The Pharma Data

MAY 5, 2021

Richard Furie, Chief of the Division of Rheumatology and Professor at the Feinstein Institutes for Medical Research at Northwell Health, and Lead Investigator of the BLISS-LN study commented : “This achievement is derived from decades of research. Premedication: An antihistamine, with/without an antipyretic, may be administered.

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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. That revised version remains in use today ( more on this below ). This was an area that FDA investigators recently interviewed by the U.S.

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Agency IQ

JUNE 2, 2023

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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Agency IQ

OCTOBER 27, 2023

The current Primary Magnesium Refining NESHAP was promulgated pursuant to CAA section 112(d) on October 10, 2003. The Rubber Tire Manufacturing NESHAP, subpart XXXX, was promulgated pursuant to section 112(d) of the Clean Air Act (CAA) on July 9, 2002, with corrections promulgated on March 12, 2003.

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Agency IQ

DECEMBER 1, 2023

The current Primary Magnesium Refining NESHAP was promulgated pursuant to CAA section 112(d) on October 10, 2003. This package would propose updates to the alternative work practice as appropriate based on the review and address the issues raised for reconsideration. 2020) (LEAN).

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