How to Navigate the FDA’s Guidance on Rare Diseases: A Guide for Biopharma Companies

By Modality Solutions

The biopharmaceutical industry is at a pivotal moment, particularly those involved in developing drugs for rare diseases.

The recent guidance from the FDA on “Rare Diseases: Considerations for the Development of Drugs and Biological Products” does not signal a paradigm shift in regulatory expectations. However, this guidance extends significantly into biologic drug product manufacturing and cold chain logistics.

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