European Pharmaceutical Review

JULY 4, 2024

2 The prerequisite to present statistically significant evidence for having efficacies of clinical relevance is crucial because FDA requires “adequate and well-controlled” multicentre clinical studies on any new drug candidate to document and support its safety and efficacy, and imposes the maximum level of scrutiny prior to approval.

Drug Development 103

Drug Development Biosimilars Documentation Labelling 103

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). What are the latest amendments?

Biosimilars 98

Biosimilars Labelling Documentation 98

Pharmaceutical Technology

FEBRUARY 24, 2023

But the EU draft document says that the changes will make medicines more affordable, improve unequal access to medicines across the EU, and fulfil unmet patient needs. He pointed out that Europe was the first region to approve biosimilars. You can compare timelines.

Biosimilars 64

Biosimilars Documentation 64

Pharma in Brief

JANUARY 10, 2024

CIPO’s application fees – and “small entities” – are getting larger in 2024 On January 1, 2024, CIPO imposed the first substantial increases to its service fees since 2004 (see here ). Draft regulations are expected to be released for consultation in 2024. The fee increases apply to both patent and trademark applications.

Drug Pricing 52

Drug Pricing Documentation Biosimilars Vaccines 52

FDA Law Blog: Biosimilars

JANUARY 13, 2025

Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act This final guidance replaces previous draft and final guidance documents on food allergen labeling that FDA issued in November 2022, which we discussed in a previous post. By Sophia R.

Documentation 105

Documentation Labelling 105