Health Regulatory Authority definition

Health Regulatory Authority means the FDA.
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Health Regulatory Authority means the statutory or Governmental Authorities authorized under applicable laws to protect and promote public and animal health through regulation and supervision of therapeutic drug candidates intended for use in humans, including, without limitation, institutional review boards, the FDA, Health Canada, the European Medicines Agency and the U.K. Medicines and Healthcare Products Regulatory Authority;
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Health Regulatory Authority means any Governmental Authority administering, overseeing, or regulating any certificates of need and other licensure and regulatory approvals required for the operation of the Facility (including any approvals required to obtain reimbursement under Medicare, Medicaid and CHAMPUS, and other Department of Veterans Affairs benefits, as applicable.)
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Examples of Health Regulatory Authority in a sentence

  • Exhale shall inform and consult with Schering prior to each regulatory submission to the Health Regulatory Authority, provided however, that prior to and following Regulatory Approval or Orphan Drug Approval, Exhale shall be solely responsible for * CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION interactions with Health Regulatory Authority.

  • Borrowers shall correct any deficiency on any report delivered pursuant to this Section 4.6 or otherwise received by Borrowers within the date required by the Health Regulatory Authority or other such government agency.

  • MILESTONES PAYMENT (US$) Upon first acceptance for filing of the Product NDA in the Field by the Health Regulatory Authority 7,000,000 [***] [***] [***] [***] [***] [***] Exhale shall notify Schering promptly in writing of the occurrence of any of the above milestones.

  • Any subcontracting which requires notification of the Health Regulatory Authority shall be subject to CoTherix’ consent; such consent not to be withheld unreasonably.

  • MILESTONES PAYMENT (US$) Upon first acceptance for filing of the Product NDA in the Field by the Health Regulatory Authority 7,000,000 Upon Regulatory Approval of the Product in the Field by the Health Regulatory Authority 9,000,000 When annual Net Sales of the Product first exceed US$ 25 million 4,000,000 When annual Net Sales of the Product first exceed US$ 100 million 10,000,000 Exhale shall notify Schering promptly in writing of the occurrence of any of the above milestones.

  • Schering agrees that any changes in the manufacture of the Product affecting the Marketing Authorization must be previously authorized in writing by NexMed within thirty days (30) from receipt hereof, even if imposed by the local Health Regulatory Authority.

  • Schering shall be entitled to appoint an Affiliate or any Third Party as subcontractor for the full or partial Manufacturing and Packing of Clinical Development Product and Commercial Product without CoTherix’ consent, only in those instances where CoTherix would not be required to notify the Health Regulatory Authority of the respective subcontracting.

  • BMS hereby covenants that [THIS PORTION HAS BEEN REDACTED] it will not take any action that seeks to block or delay (or has the effect of blocking or delaying) approval by the Canadian Health Regulatory Authority of a Canadian equivalent of a Paclitaxel ANDA or marketing of paclitaxel in Canada pursuant to a Canadian equivalent of a Paclitaxel ANDA solely for the treatment of second line ovarian cancer or metastatic breast cancer.

  • The Parties will assist each other in investigating any such situation and all regulatory contacts that are made and all activities concerning seizure, recall, withdrawal or field correction will be jointly coordinated by Schering and CoTherix, with CoTherix serving as the primary point of contact for communications involving the Health Regulatory Authority.

  • For the avoidance of doubt, any official advice received from a relevant Health Regulatory Authority regarding the requirements of GMP will be conclusive, unless Praecis can reasonably demonstrate that such advice is erroneous, and, unless Praecis so demonstrates, Praecis will implement any such requirements.


More Definitions of Health Regulatory Authority

Health Regulatory Authority means EMEA, the national competent authorities of the EU member states, FDA and any other government entity that has jurisdiction to grant Regulatory Approvals, including, but not limited to, Marketing Authorizations, for the Product in the Territory.
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Health Regulatory Authority means the Governmental Bodies authorized under applicable Laws to protect and promote public through the regulation and supervision of medical products, including, without limitation, Health Canada, the United States Food and Drug Administration, the European Medicines Agency and similar regulatory agencies having jurisdiction over the Corporation or its activities;
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Health Regulatory Authority means as Authority constituted by Government under section 20 for the purposes mentioned in the said section;
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Health Regulatory Authority means Health Canada;
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Related to Health Regulatory Authority

  • national regulatory authority means the body or bodies charged by a Member State with any of the regulatory tasks assigned in this Directive and the Specific Directives;

  • Regulatory Authority means, with respect to any national, supra-national, regional, state or local regulatory jurisdiction, any agency, department, bureau, commission, council or other governmental entity involved in the granting of a Regulatory Approval for such jurisdiction.

  • Insurance Regulatory Authority means, with respect to any Insurance Subsidiary, the insurance department or similar Governmental Authority charged with regulating insurance companies or insurance holding companies, in its jurisdiction of domicile and, to the extent that it has regulatory authority over such Insurance Subsidiary, in each other jurisdiction in which such Insurance Subsidiary conducts business or is licensed to conduct business.

  • Regulatory Authorities means the Commissions and the Exchange;

  • foreign regulatory authority means a securities commission, exchange or other securities market regulatory authority in a designated foreign jurisdiction;

  • Relevant Electric Retail Regulatory Authority means an entity that has jurisdiction over and establishes prices and policies for competition for providers of retail electric service to end- customers, such as the city council for a municipal utility, the governing board of a cooperative utility, the state public utility commission or any other such entity.

  • Foreign Financial Regulatory Authority shall have the meaning given by Section 2(a)(50) of the 0000 Xxx.

  • FDA means the United States Food and Drug Administration.

  • securities regulatory authority or “SRA” means a body created by statute in any Canadian or foreign jurisdiction to administer securities law, regulation and policy (e.g. securities commission), but does not include an exchange or other self regulatory entity;

  • Applicable Insurance Regulatory Authority means the insurance department or similar insurance regulatory or administrative authority or agency of the jurisdiction in which the Company is domiciled.

  • Securities Regulatory Authorities means the securities commission or similar regulatory authority in each province and territory of Canada that is responsible for administering the Canadian securities legislation in force in such jurisdictions;

  • Regulatory Authorizations means all approvals, clearances, authorizations, registrations, certifications, licenses and permits granted by any Regulatory Authority.

  • Public Procurement Regulatory Authority (PPRA) means the Government Agency responsible for oversight of public procurement.

  • Cemetery authority means any person who owns or operates a cemetery specified in s. 157.065 (1).

  • statutory authority means Central or State Government, quasi-Government, administrative, judicial, public or statutory body, department, instrumentality, agency, authority, board entrusted with and carrying any statutory functions, as required from time to time in connection with performance by the Preferred Bidder of its obligations hereunder;

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • CFDA means the Code of Federal Domestic Assistance assigned to a federal grant.

  • Regulatory entity means any board, commission, agency,

  • MHLW means the Ministry of Health, Labour and Welfare of Japan, or the successor thereto.

  • Regulatory Agency means any federal or state agency charged with the supervision or regulation of depositary institutions or holding companies of depositary institutions, or engaged in the insurance of depositary institution deposits, or any court, administrative agency or commission or other authority, body or agency having supervisory or regulatory authority with respect to the Company or any of its subsidiaries.

  • Health Authority means the regional health board designated under the Health Authority Act, RSBC 1996, c.180, or the Provincial Health Services Authority, to which the Participant is designated under Section 5.4 of this Contract, unless designated otherwise by the Province;

  • Marketing Authorization Application or “MAA” means an application to the appropriate Regulatory Authority for approval to sell the Product (but excluding Pricing Approval) in any particular country or regulatory jurisdiction.

  • Public health authority means an agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate.

  • Regulatory Law means the Xxxxxxx Act, as amended, the Xxxxxxx Act, as amended, the HSR Act, the Federal Trade Commission Act, as amended, and all other federal, state and foreign, if any, statutes, rules, regulations, orders, decrees, administrative and judicial doctrines and other laws that are designed or intended to prohibit, restrict or regulate actions having the purpose or effect of monopolization or restraint of trade or lessening of competition through merger or acquisition.

  • Regulatory Laws means the HSR Act, the Xxxxxxx Antitrust Act of 1890, as amended, and the rules and regulations promulgated thereunder, the Xxxxxxx Act of 1914, as amended, and the rules and regulations promulgated thereunder, the Federal Trade Commission Act of 1914, as amended, and the rules and regulations promulgated thereunder, and any other federal, state and foreign statutes, rules, regulations, orders, decrees, administrative and judicial doctrines and other Laws that are designed or intended to prohibit, restrict or regulate actions having the purpose or effect of monopolization or restraint of trade or lessening of competition through merger or acquisition.

  • Drug abuse means any pattern of pathological use of drugs that causes impairment in social or occupational functioning, or that produces physiological dependency evidenced by physical tolerance or by physical symptoms when it is withdrawn.