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 designation as an orphan drug or equivalent under relevant national or other applicable regulations and/or legislation in any part of the world, including under the US Orphan Drug Act of 1983 or Orphan Drug Regulation 141/2000 in the European Union
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
Business Review January – December 2015 Hansa Medical received FDA Orphan Drug Designation for IdeS The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to IdeS for the prevention of antibody mediated organ rejection in patients undergoing solid organ transplant pa- tients.
More Definitions of Orphan Drug Designation
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 the granting of special status by a country and/or government regulatory agency (such as the FDA, European Medicines Agency (EMA), Japanese Ministry of Health, Labour and Welfare (MHLW), or Therapeutics Goods Administration (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 the orphan designation for the Licensed Product in the treatment of Huntington’s Disease issued by the Office of Orphan Products Development, under authority of FDA, on 6 April 2000 and the EMEA Committee for Orphan Medicinal Products on 27 October 2000;
Orphan Drug Designation. Business - Patent Protection and Intellectual Property; Orphan Drug; Xxxxx-Xxxxxx Act; Pediatric Treatment Exclusivity - The Xxxxx-Xxxxxx Act"; "Business - Patent Protection and Intellectual Property; Orphan Drug; Xxxxx-Xxxxxx Act; Pediatric Treatment Exclusivity - Pediatric Treatment Exclusivity"; "Business - Government Regulation - United States Government Regulation"; "Business - Third Party Reimbursement and Pricing Controls"; "Description of Capital Stock" and "Underwriters" (only with respect to the description of the Underwriting Agreement) and Items 14 and Item 15 of Part II of the Registration Statement, and insofar as such statements constitute summaries of legal matters, contracts, agreements, documents or proceedings referred to therein, or refer to statements of law or legal conclusions, such statements are accurate in all material respects and fairly present the information purported to be shown;
Orphan Drug Designation means the designation that the MHLW may grant if (1) the number of patients who may use the drug are less than 50,000 in Japan, (2) the drug is indicated for the treatment of patients with serious diseases, including the difficult-to-treat diseases and (3) there is no appropriate alternative drug or treatment, or higher efficacy or safety is expected compared with existing products. Orphan Drug Designation provides an extension of the re-examination period up to 10 years. In case the MHLW or the government of Japan revise or replace such system for orphan drugs, the revised or similar system shall apply.
Orphan Drug Designation means FDA’s act of granting a request for des- ignation under section 526 of the act.