Advertising

03
Feb
Developing marketing strategy. Development of effective solution.

Promotional Labeling is the Target of New Q&A Document on Biosimilars and Reference Products

Today, the FDA released a guidance document titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products: Questions and Answers (here).  The document provides the FDA’s responses to eight questions designed to help firms assure that they do not run afoul in advertising or promotion when describing similarities and differences between the […]

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07
May

Accelerated Approval and DTC Advertising – FDA Proposes a Study to Inform Which Direction to Take

In the Federal Register (FR) pre-publication page (here) today, FDA announced a proposed study to evaluate patient/consumer ability to understand the impact of Direct to Consumer (DTC) advertising for products with accelerated approvals.  These products are typically approved based on a surrogate endpoint (such as a blood test) that has a reasonable likelihood to predict […]

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