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Developing Products for Rare Diseases & Conditions

Per FDA, The Office of Orphan Products Dedicated to Products for Rare Diseases and Conditions

The Food and Drug Administration has charged The Office of Orphan Products Development (OOPD) to dedicate its mission to promoting the development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. In fulfilling that task, OOPD interacts with the medical and research communities, professional organizations, academia, governmental agencies, and the pharmaceutical industry, as well as rare disease groups.

The OOPD administers the major provisions of the Orphan Drug Act (ODA) which provide incentives for sponsors to develop products for rare diseases. The ODA has been very successful - more than 200 drugs and biological products for rare diseases have been brought to market since 1983. In contrast, the decade prior to 1983 saw fewer than ten such products come to market.

In addition, the OOPD administers the Orphan Products Grants Program which provides funding for clinical research in rare diseases. The Office Of Orphan Products Development will also administer a new grant program, the Pediatric Device Consortia (PDC) Grant Program. The PDC Grant Program solicits grant applications from institution/organizations that propose to develop nonprofit consortia to facilitate pediatric medical device development. FDA will provide grants to consortia whose business model and approach to device development will either result in, or substantially contribute to, market approval of medical devices designed specifically for use in children. Although administered by the OOPD, this grant program is intended to encompass devices used in all pediatric diseases not just rare diseases.

SOURCE:

U.S. Food and Drug Administration



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