2009 Biosimilars Labelling 
FDA Law Blog: Biosimilars
OCTOBER 24, 2023
Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP).
European Pharmaceutical Review
DECEMBER 20, 2023
Changes to regulatory data protection periods are of particular interest to biopharma” Changes to regulatory data protection (RDP) periods are of particular interest to biopharma (originators and generic / biosimilar manufacturers). analysis (Source: L.E.K) By contrast, orphan drugs could become less profitable, more risky investments.
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pharmaphorum
JULY 2, 2025
Her career kicked off at 18, when she landed a role at Check Point after successfully cracking a series of online cybersecurity challenges the company had labelled as nearly unsolvable. Website and content copyright © 2009- 2025 , pharmaphorum media limited or its licensors; all rights reserved. pharmaphorum – an EVERSANA company
FDA Law Blog: Biosimilars
JANUARY 22, 2025
Wasserstein & Dara Katcher Levy Who among us, upon reading FDAs draft guidance on the distribution of off label information and their coining of the acronym SIUU (standing for Scientific Information on Unapproved Uses ) did not automatically think of Phil Collins classic song Sussudio ? By Jeffrey N. Other than anyone under 50, that is.
PharmaShots
APRIL 13, 2023
2009 was a challenging year for multinational companies due to the recession and currency fluctuations Johnson & Johnson's performance graph declined by 2.9% Despite a challenging year, Johnson & Johnson acquired Cougar and Elan Pfizer's 2009 performance was significant as compared to 2008 with the addition of Wyeth.
pharmaphorum
FEBRUARY 26, 2021
Robert Wood’s granddaughter, Mary Lea, was the first baby to be used on the baby powder label. The litigation was settled in 2009, when Boston Scientific agreed to pay $716 million in September and an additional $1.73 Johnson’s Baby Powder also went on sale during this year and was extremely successful.
pharmaphorum
JULY 7, 2025
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued clear guidance for incorporating RWE in regulatory submissions, labelling expansions, and post-market monitoring. Website and content copyright © 2009- 2025 , pharmaphorum media limited or its licensors; all rights reserved.
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