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] Resources [1] 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. Make patients aware of potential risk of hypersensitivity reactions (day of, or several days after infusion, including signs/symptoms and recurrence) and provide package leaflet each time Benlysta 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. 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 2, 2023

FDA unveils long-awaited Patient Medication Information proposed rule Since 2017, the FDA has been working on a proposal to create a new type of patient-focused labeling for certain outpatient drug products that would be specifically targeted for patient use. The FDA recently concluded its work on a proposed rule focused on PMI.

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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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Agency IQ

MARCH 29, 2024

The Iron and Steel Manufacturing Facilities NESHAP was promulgated pursuant to section 112(d) of the Clean Air Act on May 20, 2003, and subsequently amended on July 13, 2006. section 7412(d)(6). The residual risk and technology review (RTR) was promulgated pursuant to CAA sections 112(f) and 112(d)(6) on July 13, 2020.

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