2003, Packaging, Trials and Vaccine - Drug Discovery Digest

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2003

Packaging

Trials

Vaccine

European Commission approves Benlysta for adult patients with active lupus nephritis

The Pharma Data

MAY 5, 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]. Immunisation: Do not give live vaccines 30 days before, or concurrently with Benlysta.

Therapies

Therapies Disease Treatment International

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

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.

FDA

FDA Production Regulations Vaccine

European Commission approves Benlysta for adult patients with active lupus nephritis

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

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