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# FDA Moves to Expedite Rare Disease Products
- URL: https://www.fdaweb.com/fda-moves-to-expedite-rare-disease-products/
- Published: 2018-02-27T12:00:00.000Z
- Updated: 2026-09-14T23:25:35.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5140856

FDA commissioner **Scott Gottlieb** says the agency is taking new steps to support and expedite development of rare disease products. Writing in an *FDA Voice* blog [post](https://blogs.fda.gov/fdavoice/index.php/2018/02/taking-new-steps-to-meet-the-challenges-of-rare-diseases-fda-marks-the-11th-rare-disease-day/?ref=fdaweb.com) to mark 2/28 as the 11th Rare Disease Day, Gottlieb identifies the actions as: 

- a new pilot for more efficient orphan designation requests, including a new fillable form to make the submission process easier for sponsors to complete designation requests and make it more efficient for FDA to review;
- a new Memorandum of Understanding with the National Organization for Rare Disorders to conduct outreach with the agency’s new patient affairs staff on ways to incorporate patient experience into regulatory discussions, including a joint series of pilot listening sessions on rare diseases; and
- a public meeting to help FDA prepare for the changing landscape of orphan drug development posed by the growth in targeted therapies and molecularly defined diseases.

 Gottlieb also says FDA has created an enhanced Web page with videos from the three Center directors plus other materials to give the public a more complete discussion of the scope of the agency’s rare disease activities.

“Over the course of 2018 we’ll continue our efforts to increase the consistency and efficiency of our reviews of rare disease products,” he concludes. “We remain committed to supporting rare disease research on diagnostics, therapies, and potential cures. We’ll also continue to evaluate how to best support investment in rare diseases, and to encourage the development of drugs that target rare, unmet patient needs.”