Orphan Drug Designation definition

Orphan Drug Designation means the special designation of Product by FDA’s Orphan Product Division which provides the Product with the opportunity to obtain additional market exclusivity from the date the drug receives FDA approval and also possible tax and regulatory approval benefits. The term “Orphan Drug Designation” shall include any foreign counterparts of the foregoing.
Orphan Drug Designation means a grant by the FDA of a request for designation under Section 526 of the Federal Food, Drug, and Cosmetic Act as amended by section 2 of the Orphan Drug Act (sections 525-528 (21 U.S.C. 360aa-360dd)) in the United States or any analogous grant by a Regulatory Authority in any other country in the Territory.
Orphan Drug Designation means designation by the EMEA as an orphan drug, a drug for a specified rare disease or condition, or the equivalent designation by a Regulatory Authority of any country of the Territory.

Examples of Orphan Drug Designation in a sentence

  • The acquired assets will include all intellectual and work property derived from pre-clinical research activities from the National Health Research Institutes (NHRI) in traumatic brain injury and stroke, as it relates to psilocybin with the aim to obtain FDA Orphan Drug Designation.

  • The FDA Office of Orphan Products Development grants Orphan Drug Designation to drugs and biologics to encourage the development of new medicines for the safe and effective treatment of underserved, rare diseases or disorders that affect less than 200,000 patients in the U.S. The Orphan Drug Designation qualifies Arch for a seven-year term of market exclusivity to sell AB569 in the U.S. following FDA approval of the drug.

  • Additionally, as Arch takes AB569 through the regulatory and human trial process, the Orphan Drug Designation provides an accelerated review and approval process, potential grant funding, tax benefits and an exemption from certain user fees.

  • Further, Relief is in clinical development for APR-TD011, a differentiated acid oxidizing solution of hypochlorous acid intended for the treatment of epidermolysis bullosa (“EB”), a group of rare, genetic, life-threatening connective tissue disorders; APR-TD011 has been granted Orphan Drug Designation by the FDA.

  • ARIAD shall cooperate reasonably with Bellicum, as requested by Bellicum and at Bellicum’s expense, in Bellicum’s efforts to maintain the Orphan Drug Designation.


More Definitions of Orphan Drug Designation

Orphan Drug Designation means a pharmaceutical agent developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government assistance.
Orphan Drug Designation means the request for designation of AP1903 for the treatment of GvHD as an orphan drug under 21 C.F.R. §316.20 that has been granted by the FDA under 21 C.F.R. §316.24.
Orphan Drug Designation means the designation of the approval process, as granted by the FDA and/or EMEA;
Orphan Drug Designation means any designation of a Product as an orphan medicinal product under Regulation (EC) No. 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (or equivalent Laws in jurisdictions other than the EU) which results from submission of an application to EMEA, the Committee for Orphan Medicinal Products (COMP), the European Commission and any comparable designation which results from a comparable submission to any other national or supranational body concerned with the application for, or maintenance of, orphan medical product designations, including the FDA.
Orphan Drug Designation means the FDA orphan drug designation dated January 10, 2000 received by Debiovision for the EVB Indication.
Orphan Drug Designation means the granting of special status by a country and/or government regulatory agency (such as the FDA, EMA, MHLW, or TGA) to a drug or biological product (“drug”) to treat a rare disease or condition upon request of a sponsor under the U.S. Orphan Drug Act (ODA) or any foreign equivalent(s) to this law enacted by other countries including but not limited to Australia, member countries of European Union, and Japan.
Orphan Drug Designation means FDA’s act of granting a request for des- ignation under section 526 of the act.