Remove 2003 Remove Packaging Remove Research Remove Vaccine
article thumbnail

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

article thumbnail

European Commission approves Benlysta for adult patients with active lupus nephritis

The Pharma Data

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

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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. While the SRP could be used to submit information on drugs and biological products, the only exception was for vaccines.

FDA 40
article thumbnail

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).

FDA 40
article thumbnail

Muscle Imbalances RevealedMuscle Imbalances Revealed

The Pharma Data

I began to research what I was missing from my exercise toolbox when it came to getting the fastest and best results for my clients. Fitness professionals work long hours and it is difficult to find the time or energy to sit down and read a textbook on exercise physiology or to look up the latest research articles. s a topic Iâ??ve