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

  • These include: • reducing significantly the delays in trials by automating the courts (Fast Track Courts) • using law as a tool for development by supporting the creation of commercial courts and the Business Law Division of the Attorney General's Department • using law as a tool for the promotion and protection of fundamental human rights and freedoms.

  • Frequently Asked Questions on Pediatric Exclusivity (505A), the Pediatric “Rule,” and Their Interaction.

  • Other Pediatric Exclusivity Information FDA maintains a website containing extensive information about pediatric exclusivity at http://www.fda.gov/cder/pediatric.

  • Cephalon shall reasonably cooperate with Xxxx in notifying the FDA that Cephalon has waived Pediatric Exclusivity with respect to Xxxx, including, but not limited to, by filing with the FDA a dated and executed copy of the letter attached hereto as Exhibit H.

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

  • 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.

  • As noted during the meeting with the Pediatric Exclusivity Board and in the Statistical Review, the Written Request stated that the study must be powered to detect a 3-mmHg effect on blood pressure.

  • 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.

  • Pediatric Exclusivity: Pediatric Exclusivity has been granted, effective October 3, 2017.

  • See also the FDA’s Pediatric Exclusivity Granted web page at https://www.fda.gov/drugs/development-resources/pediatric-exclusivity-granted.


More Definitions of Pediatric Exclusivity

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 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 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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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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Related to Pediatric Exclusivity

  • Regulatory Exclusivity means any exclusive marketing rights or data exclusivity rights conferred by any Regulatory Authority with respect to a pharmaceutical product other than Patents, 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 confers exclusive marketing rights with respect to such Licensed Product in such country or prevents another Person from using or otherwise relying on any data supporting the approval of the Drug Approval Application for such Licensed Product to support an application for regulatory approval of another product for any indication without the prior written consent of the Drug Approval Application holder.

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • 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: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).

  • 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 a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • Licensed Compound means [***].

  • 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.

  • Royalty Term means, on a country-by-country basis, the period commencing on the First Commercial Sale of a Licensed Product in a country and ending on the latest of (a) ** thereafter, (b) expiration of the last-to-expire Valid Claim of a Licensed Patent that Covers the composition of matter of the Licensed Product in the country in which it is sold, or (c) the expiration of all Regulatory Exclusivity Rights with respect to such Licensed Product in the country in which it is sold.

  • 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 restoration by existing or future extension or restoration mechanisms (including, without limitation, supplementary protection certificates or the equivalent thereof), 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.

  • Collaborating physician means the physician who,

  • Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.

  • Licensed Service means a service provided using Licensed Products or Licensed Methods, including, without limitation, any such service provided in the form of contract research or other research performed by Licensee on behalf of a third party.