Post-Approval Studies definition

Post-Approval Studies means any human clinical trials or studies, including marketing studies, epidemiological studies, modeling and pharmacoeconomic studies, investigator sponsored clinical trials and post-marketing surveillance studies, of the Licensed Product, other than Phase 4 Clinical Trials, that are conducted after receipt of Regulatory Approval and that are not intended for use as a basis for obtaining or maintaining such Regulatory Approval. For clarity, Post-Approval Studies shall be considered part of Commercialization.
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Post-Approval Studies means a pharmaceutical product (including any future formulation), which contains only Olmesartan plus Rosuvastatin fixed dose combination (FDC) to be used with Therapeutic Drug Monitoring (TDM)for recalcitrant or resistant HTN. All Intellecture Properties of TDM are exclusively owned by AUTOTELIC, and AUTOTELIC will grant a royalty bearing non-exclusive license to use in conjunction with the a pharmaceutical product (including any future formulation), which contains only Olmesartan plus Rosuvastatin fixed dose combination (FDC). means a human clinical study, or other test or study with respect to a product for an indication that (a) is conducted solely in support of pricing or reimbursement for such product in the Territory or (b) is not required to obtain or maintain Marketing Authorization for such product for such indication (for clarity, any human clinical study that is intended to expand the label for a product shall be a Clinical Trial). Subject to the foregoing, Post Approval Studies may include epidemiological studies, modelling and pharmacoeconomic studies, post-marketing surveillance studies, investigator sponsored studies and health economics studies, but shall exclude Phase IV Clinical Trials.
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Post-Approval Studies means any pre-clinical or clinical studies for a Licensed Product (or for the Drug Substance therein) commenced after receipt of Regulatory Approval for such Licensed Product, that are not Required Studies.
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Examples of Post-Approval Studies in a sentence

  • For more information on post-approval studies, see the FDA guidance document entitled, "Procedures for Handling Post-Approval Studies Imposed by PMA Order" (https://www.fda.gov/media/71327/download).

  • Post-Approval Studies (PAS): MED-EL New Enrollment SSD/AHL Study.

  • For more information on post-approval studies, see the FDA guidance document entitled, "Procedures for Handling Post-Approval Studies Imposed by PMA Order" (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm0 70974.htm).

  • For more information on post-approval studies, see the FDA guidance document entitled, "Procedures for Handling Post-Approval Studies Imposed by PMA Order" (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070974.htm).

  • For more information on post-approval studies, see the FDA guidance document entitled, "Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order" (https://www.fda.gov/media/71327/download).

  • Be advised that protocol information, interim and final results will be published on the Post-Approval Studies Program Database Webpage https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm.

  • FDA required post-market surveillance and Post-Approval Studies are considered “FDA-Regulated Medical Device Studies” for purposes of this memo.

  • Saraswati, T.S (ed), 1999-Cultural, Socialization and Human Development: Theory, research and Application in India, Sage, new Delhi.2. Vasante, D.

  • Postmarket Requirements (Medical Devices): Post-Approval Studies.

  • Each Party will notify the other Party in reasonable detail of any such complaints within sufficient time to allow the other Party and its Related Parties to comply with any and all regulatory and other requirements imposed upon them in any jurisdiction in which the Covered Product is being marketed or tested in Clinical Studies and/or Post-Approval Studies.


More Definitions of Post-Approval Studies

Post-Approval Studies as used in this Section 5.7 means those clinical studies required by the health regulatory authority in any country in the Territory for the Government Approval of the Finished Product for indications other than that indication for which a Government Approval has already been received in such country or for a Government Approval to use the Finished Product as part of a combination therapy.
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Post-Approval Studies means studies conducted with a Licensed Product after the receipt of the first Regulatory Approval of such Licensed Product.
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Post-Approval Studies means any post-approval study as required by the EMA, including any post-authorization safety study and any pediatric clinical study, in each case, related to the Licensed Product conducted with the aim of identifying, characterizing, or quantifying a safety hazard, confirming the safety profile of the Licensed Product, or of measuring the effectiveness of risk management measures.
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Related to Post-Approval Studies

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Development approval means any written authorization from a

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Regulatory Approval means any approval or clearance by any governmental agency or agencies having authority to regulate the use or sale of any Licensed Product(s) in the pertinent jurisdiction or territory.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • Development Approvals means all permits, licenses, and/or other entitlements for the Development of the Property, including any and all conditions of approval, subject to approval or issuance by the City in connection with Development of the Property including:

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Product as a drug in a regulatory jurisdiction.

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • Phase 3 Study means a clinical study of a drug candidate in human patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to obtain Regulatory Approval in any country as described in 21 C.F.R. 312.21(c), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The relevant drug candidate may be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Pre-approval means written notification via a pre-approval letter to Customer that Ameren Illinois has reviewed Customer's Application and determined that the project meets the program eligibility requirements for a maximum pre-approved incentive amount if the project is completed by the estimated completion date and all final application paperwork is submitted and approved.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Regulatory Approvals means any registrations, licenses, authorizations, permits or approvals issued by any Governmental Authority and applications or submissions related to any of the foregoing.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • FDA Approval means the approval by the FDA of a premarket approval application to market and sell a Product, as evidenced by the publication of such approval by the FDA.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Final Approval Hearing means the hearing to be conducted by the Court to determine the fairness, adequacy, and reasonableness of the Settlement pursuant to Federal Rule of Civil Procedure 23 and whether to issue the Final Approval Order and Judgment.

  • Key Regulatory Approvals means those sanctions, rulings, consents, orders, exemptions, permits and other approvals (including the lapse, without objection, of a prescribed time under a statute or regulation that states that a transaction may be implemented if a prescribed time lapses following the giving of notice without an objection being made) of Governmental Entities as set out in Schedule C hereto;