Skip to site menu Skip to page content

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.

To read more, please download this free white paper.

Enter your details below to view the free white paper

By downloading this whitepaper, you acknowledge that GlobalData may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services.

Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Related Content