Orphan Drug definition

Orphan Drug means a drug intended to treat a condition which affects not more than five lakh persons in India;

Orphan Drug means a drug or biologic that meets the definition for “orphan drug” provided in 21 C.F.R. § 316.3(b)(10) that has been granted an orphan drug designation by the Secretary of U.S. Department of Health and Human Services under 21 U.S.C. § 360bb, and any foreign equivalents.

Orphan Drug means a Licensed Product that is protected (a) by “Orphan Drug” status under the U.S. Orphan Drug Act, (b) by a Supplementary Protection Certificate, as such term is defined in Council Regulation (EU) No. 1768/92, or (c) by a similar status granted under similar statutory provisions of another jurisdiction granting exclusive marketing rights in such jurisdiction.

Examples of Orphan Drug 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.

• L.REV 105, 119 (1995).201 See 21 U.S.C. § 360dd.202 Id.203 See Orphan Drug Regulations, 57 Fed.

• RVV CSELow0.04Sector:Website:Pharma & Biotechwww.revivethera.comCompany Synopsis:Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations.

• Orphan drug statusThe applicant requested Orphan Drug Status in accordance with Article 4 adecies no.

• Fairness in Orphan Drug Exclusivity Act (H.R. 1629): consideration of.

More Definitions of Orphan Drug

Orphan Drug means a drug intended for use in a rare disease or condition as defined by the Orphan Drug Act.

Orphan Drug means (a) a pharmaceutical product intended to treat a disease or condition that affects fewer than 200,000 people in the United States or, if the pharmaceutical product is a vaccine, diagnostic product, or preventive product, the persons to whom such product will be administered in the United States are fewer than 200,000 per year, or (b) a pharmaceutical product intended to treat a disease or condition that affects 200,000 or more people in the United States, but with respect to which product there is no reasonable expectation that the costs of research and development of such product to treat such disease or condition can be recovered by sales of such product in the United States.

Orphan Drug means a Licensed Product for a specific indication for which the FDA has granted “Orphan-drug exclusive approval” as defined in 21 CFR Paid 316 or which be granted Orphan Drug exclusivity under similar regulations in the European Union or Japan.

Orphan Drug means a Product that has been designated by the United States Food and Drug Administration pursuant to the Orphan Drug Act as a drug for a specified rare disease or condition.

Orphan Drug means a drug intended to treat a condition which affects not more than five lakh persons in India;Post-trial Access

Orphan Drug means a product that is used to treat disease that affects relatively few people and for which U.S. and foreign government authorities or agencies provide tax credits or other incentives to make it possible to provide a safe and effect medical product for the treatment of the disease.

Orphan Drug. Status" is an exclusive approval to market a therapeutic for the treatment of a human fibrotic disease based upon orphan drug status under the Orphan Drug Act of 1983 in the United States (Pub.L. 97-414, Jan.4, 1983, 96 Stat. 2049) or any corresponding or similar non-U.S. statutes, granted by the U.S. Food and Drug Administration ("FDA"), the Committee on Proprietary Medicinal Products ("CPMP") or other Regulatory Agencies in the Territory to InterMune for the anti-fibrotic uses of Pirfenidone for such disease.