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).

Labelling 64

Labelling Communication 64

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.

Biosimilars 98

Biosimilars Labelling Documentation 98

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Wasserstein & Dara Katcher Levy Who among us, upon reading FDAs draft guidance on the distribution of off label information and their coining of the acronym SIUU (standing for Scientific Information on Unapproved Uses ) did not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.

Labelling 59

Labelling Communication 59

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.

Biosimilars 40

Biosimilars Vaccines Pharmaceutical Companies Pharmaceutical Companies 40

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.

Vaccines 126

Vaccines Biosimilars Labelling Communication 126

pharmaphorum

FEBRUARY 5, 2021

The FDA did go on to add warning labels in the following years and eventually decided to require a class-wide monitoring programme, with training for doctors. He’s been closely linked to the full time job since Biden was sworn in and formerly worked as principal deputy commissioner of the FDA from 2009 until 2011. Dr Janet Woodcock.

Vaccines 119

Vaccines Biosimilars Labelling 119