Pediatric Exclusivity definition

Pediatric Exclusivity means any pediatric exclusivity rights conferred by Section 505A of the Federal Food, Drug, and Cosmetic Act (as set forth at 21 U.S.C. ch. 9 §301 et seq.) with respect to the Approved OMIDRIA Product in the United States.
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Pediatric Exclusivity means exclusivity obtained in accordance with the requirements of Federal Food, Drug, and Cosmetic Act § 505a, 21 U.S.C. 355a.
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Pediatric Exclusivity means a Market Approval issued by FDA in application of 21 C.F.R. § 355a or its successor regulation.
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Examples of Pediatric Exclusivity in a sentence

  • You should refer to the Guidance for Industry: Qualifying for Pediatric Exclusivity for details.

  • The Secretary shall make public the information described in the preceding sentence in a manner consistent with how the Secretary releases information under section 505A(k) of the Federal Food, Drug, and Cosmetic Act (21U.S.C. 355a(k)).’’Report on Pediatric Exclusivity ProgramPub.

  • Economic Return of Clinical Trials Performed Under the Pediatric Exclusivity Program.

  • Grabowski, et al., “Economic Return of Clinical Trials Performed Under the Pediatric Exclusivity Program,” Journal of the American Medical Association, vol.

  • A Second 6-Month Period of Pediatric Exclusivity Each Written Request may result in only one 6-month period of pediatric exclusivity.

  • FDA is announcing the availability of a guidance for industry entitled‘‘Qualifying for Pediatric Exclusivity Under Section 505A of the FederalFood, Drug, and Cosmetic Act.’’ Section 111 of the Modernization Act (Pub.

  • This guidance supersedes the guidance for industry on Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act that FDA issued in June 1998.

  • Pediatric Exclusivity Pediatric exclusivity will attach to exclusivity and patent protection listed in the Orange Book for any drug product containing the same active moiety as the drug studied and for which the party submitting the studies holds the approved new drug application (505A(a) and (c)).

  • It is the Committee’s belief that any manufacturer entitled to the 180 day generic exclusivity should not see any of that period evis- cerated by Pediatric Exclusivity.

  • You should refer to the Guidance for Industry on Qualifying for Pediatric Exclusivity (available on our web site at www.fda.gov/cder/pediatric) for details.


More Definitions of Pediatric Exclusivity

Pediatric Exclusivity means and refer to any exclusivity granted by the FDA for pediatric studies pursuant to § 505A of the FDC Act or any equivalent exclusivity granted by the applicable government agencies authorized to grant Market Exclusivity in a country or territory.
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Pediatric Exclusivity means the period of exclusivity provided by 21 U.S.C. § 355a(b)(1)(B) (as amended or replaced) and/or 21 U.S.C. § 355a(c)(1)(B) (as amended or replaced).
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Pediatric Exclusivity means the additional six (6) months of exclusivity extension provided under the Food and Drug Administration Modernization Act of 1997, section 505A of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(a)), or any replacement thereto. For purposes of clarification, however, Lilly, in its sole discretion, shall have the right to seek any government-conferred exclusivity available with respect to products containing the Compound, whether or not such exclusivity is based on PAH.
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Pediatric Exclusivity means the period of Regulatory Exclusivity awarded to a drug product during which FDA may not approve another drug product pursuant to 21 U.S.C. 355a(b)-(c).
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Pediatric Exclusivity means the period of exclusivity provided by 21 U.S.C. § 355a(b)(1)(B) (as amended or replaced) and/or 21 U.S.C. § 355a(c)(1)(B) (as amended or replaced). “Pending Litigation” means Cadence Pharmaceuticals, Inc. and *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
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Related to Pediatric Exclusivity

  • Regulatory Exclusivity means any exclusive marketing rights or data exclusivity rights granted by a Regulatory Authority (other than Patents) with respect to a Licensed Product sold in a given country, including orphan drug exclusivity, new chemical entity exclusivity, data exclusivity or pediatric exclusivity.

  • Exclusivity means the specificity of the test method for validating microbial testing methods. It evaluates the ability of the method to distinguish the target organisms from similar but genetically distinct non-target organisms.

  • Regulatory Exclusivity Period means, with respect to each Licensed Product in any country in the Territory, a period of exclusivity (other than Patent exclusivity) granted or afforded by Applicable Law or by a Regulatory Authority in such country that prevents the approval or marketing of any Biosimilar Product of such Licensed Product in such country.

  • Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.

  • Therapeutic school means a residential group living facility:

  • Pre-Licensed Therapist means an individual who has obtained a Master’s Degree in Social Work or Marriage and Family Therapy and is registered with the BBS as an Associate CSW or MFT Intern acquiring hours for licensing. An individual’s registration is subject to regulations adopted by the BBS.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Patent Term Extension means any term extensions, supplementary protection certificates and equivalents thereof offering Patent protection beyond the initial term with respect to any issued Patents.

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

  • Licensed Compound means (a) 3,4-Diaminopyridine, the chemical structure of which is set forth on Exhibit B-2; and (b) any derivatives, isomers, metabolites, prodrugs, acid forms, base forms, salt forms, or modified versions of such compound in (a).

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Therapeutic Equivalent means that a Covered Drug can be expected to produce essentially the same therapeutic outcome and toxicity.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Opioid antidote means any drug, regardless of dosage amount or method of administration, which has been approved by the United States Food and Drug Administration (FDA) for the treatment of an opioid overdose. “Opioid antidote” includes, but is not limited to, naloxone hydrochloride, in any dosage amount, which is administered through nasal spray or any other FDA-approved means or methods.

  • Royalty Term means, with respect to each Licensed Product, the period of time beginning on the first sale of a Licensed Product in a country following receipt of regulatory approval for the marketing and sale of such Licensed Product in such country and continuing on a country-by-country and product-by-product basis until the later of (1) the expiration of the Patent Term, or (ii) ten (10) years from the date of such sale of such Licensed Product in such country (other than any sale or transfer between Licensee and its Affiliates or Sublicensees).

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Gene Therapy means the introduction of a nucleic acid sequence encoding a protein intended for or otherwise conferring therapeutic benefit into a person for therapeutic purposes (i) by in vivo introduction for incorporation into cells of such person, or (ii) by ex vivo introduction into cells for transfer into a person.

  • NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.

  • Licensed physician means a person licensed to practice

  • Therapeutic care means services provided by licensed or certified speech pathologists, Occupational Therapists and Physical Therapists.

  • geographical indication , in relation to goods, means an indication which identifies such goods as agricultural goods, natural goods or manufactured goods as originating, or manufactured in the territory of a country, or a region or locality in that territory, where a given quality, reputation or other characteristic of such goods is essentially attributable to its geographical origin and in case where such goods are manufactured goods one of the activities of either the production or of processing or preparation of the goods concerned takes place in such territory, region or locality, as the case may be.

  • Patent Right means: (a) an issued or granted patent, including any extension, supplemental protection certificate, registration, confirmation, reissue, reexamination, extension or renewal thereof; (b) a pending patent application, including any continuation, divisional, continuation-in-part, substitute or provisional application thereof; and (c) all counterparts or foreign equivalents of any of the foregoing issued by or filed in any country or other jurisdiction.

  • Coverage territory means the United States of America (including its territories and possessions), Puerto Rico and Canada.

  • Reference biological product means the single biological product licensed pursuant to 42 U.S.C.

  • Collaborating physician means the physician who,