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USFDA Q&A: Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products
As biosimilars and interchangeable biosimilars become an integral part of modern biologic therapy, promotional communications around these products require heightened regulatory care. To address recurring industry questions and reduce the risk of misleading claims, the FDA has issued the guidance Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products . Published in 12 Dec
Sharan Murugan
Dec 13, 20254 min read
UK MHRA Guidance: Blue Guide -Advertising and Promoting Medicines – A Regulatory Overview
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has updated the Appendix 4 Best Practice Guidance of the " Blue Guide:...
Sharan Murugan
Mar 30, 20252 min read
USFDA Guidance: Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Q&A
On 24 April 2026 (Wednesday) the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research released a...
Sharan Murugan
Apr 27, 20242 min read
USFDA Guidance: Risk & Efficacy Information in Direct-to Consumer Prescription Drug Promo Labeling
A final guidance for the industry was issued today (27 June, 2023) by the US Food and Drug Administration titled "Presenting Quantitative...
Sharan Murugan
Jun 27, 20231 min read
TGA guidance on Testimonials & Endorsements in Advertising
As part of its updated guidelines on testimonials and endorsements in advertising, the Therapeutic Goods Administration (TGA) updated its...
Sharan Murugan
Jun 3, 20221 min read
FDA Guidance:Providing Submissions in Electronic & Non-Elec Format—Promotional Labeling &Advertising
On 11-March-2022, FDA released the final guidance "Providing Regulatory Submissions in Electronic and Non-Electronic 1 Format —...
Sharan Murugan
Apr 13, 20222 min read