FDA Requirements definition

FDA Requirements means any requirements of the Federal Food, Drug and Cosmetic Act, as amended, and any rules or regulations promulgated thereunder which are or may be applicable to the manufacture, sale, labeling or distribution of the Products.
View Source
FDA Requirements means the FDCA and applicable regulations (excluding regulations governing current good manufacturing practices) ofthe FDA governing the distribution, sale, detailing, marketing, advertising, promotion, branding, or disseminating of information about Evista in the United States.
View Source
FDA Requirements is defined in Section 4.32.
View Source

Examples of FDA Requirements in a sentence

  • Federal Drug Agency (FDA) Requirements: Medical device, food, food additive, cosmetic, laser or light emitting diode, radiation-emitting device shall include the manufacturer’s address, any registration numbers, and any accession codes or reasons why product is exempt from FDA requirements.

  • Licensee hereby agrees that all Products sold in connection with the Trademarks shall fully comply with (i) all FDA Requirements (ii) all other legal requirements imposed by any other Governmental Authority, and (iii) the applicable Product Standards.

  • After the Effective Date, the Chief Compliance Officer shall be responsible for directing and implementing systems, processes, policies, and procedures to promote and require compliance with this Decree, FDA Requirements, and Federal l-lealth Care Program Requirements.

  • JDoherty Unotech Agreement Draft 4-19-01 04/19/01 Quality Control and FDA Requirements: Matritech will assist Unotech in defining processes and procedures necessary to assure compliance with all FDA requirements for Good Manufacturing Practices.

  • Seller has provided or made available to Buyer all documents and communications in its possession concerning communications from, and to, the FDA and any other Governmental Body or prepared by the FDA or any other Governmental Body that bear in any material respect on compliance by the Business with the FDA Requirements (as listed on Schedule 4.32, the “FDA Documents”).

  • Neither the Company nor any of its Subsidiaries has received any written notice from the FDA or any comparable state or non- U.S. Regulatory Authority alleging that the Company, any Subsidiary or any Company Product is not in compliance with FDA Requirements, nor is there any reasonable basis for such a notice.

  • Except as otherwise indicated on Schedule 4.32 or the FDA Documents, Seller has not received any written notice or, to the Knowledge of Seller, other communication from the FDA or other Governmental Body alleging any violation of the FDA Requirements.

  • To the extent required by a Governmental Entity, all labeling used on the Inventory has been filed or registered with and/or approved by each Governmental Entity that required such filing, registration and/or approval and is otherwise in compliance with all applicable FDA Requirements.

  • Licensee hereby agrees that all products sold in connection with the Trademarks shall fully comply with (i) all FDA Requirements (ii) all other legal requirements imposed by any other Governmental Authority, and (iii) the applicable Product Standards.

  • As used herein, the term "ENVIRONMENTAL REQUIREMENTS" means all applicable present and future Environmental Laws and all rules, regulations, orders, decrees, permits, licenses, concessions, franchises, or other restrictions or requirements of any Governmental Authority relating to protection of human health or the environment and all applicable judicial, regulatory, or administrative decisions, decrees, judgments, or orders thereunder, but excluding FDA Requirements.


More Definitions of FDA Requirements

FDA Requirements means all applicable Legal Requirements (including, but not limited to, Section 321 et. seq. of Title 21 of the FDCA) administered or issued by the FDA or any applicable, comparable state or foreign Governmental Body having equivalent authority over medical devices, including requirements related to premarket clearance, exemption from premarket clearance, premarket approval, establishment registration and product listing, medical device reporting, corrections and removals, recalls, import and export requirements, product labeling, promotional materials and advertising, supplier qualification, purchasing controls, product testing, quality system regulation, and good manufacturing practices.
View Source

Related to FDA Requirements

  • OHS Requirements means all Laws applicable to the Supply and related to occupational health or safety, and all of the City Policies that relate to occupational health or safety, and includes without limitation the WCA;

  • Program Requirements means that Partner has to fulfill certain program requirements as described in detail in the applicable SAP PartnerEdge Model and the PartnerEdge Program Guide.

  • Pretreatment requirements means any substantive or procedural requirement related to pretreatment, other than a pretreatment standard, imposed on an industrial user.

  • MREL Requirements means the laws, regulations, requirements, guidelines, rules, standards and policies relating to minimum requirements for own funds and eligible liabilities applicable to the Issuer and/or the Group, from time to time, (including any applicable transitional or grandfathering provisions), including, without limitation to the generality of the foregoing, any delegated or implementing acts (such as regulatory technical standards) adopted by the European Commission and any regulations, requirements, guidelines, rules, standards and policies relating to minimum requirements for own funds and eligible liabilities adopted by the Federal Republic of Germany or the Republic of Italy, a relevant resolution authority or the European Banking Authority from time to time (whether or not such requirements, guidelines or policies are applied generally or specifically to the Issuer and/or the Group), as any of the preceding laws, regulations, requirements, guidelines, rules, standards, policies or interpretations may be amended, supplemented, superseded or replaced from time to time.

  • Minimum Requirements means the minimum requirements for available commercial structures. The minimum requirements may be found at this link: https://portlandgeneral.com/energy- choices/renewable-power/green-future-impact The minimum requirements may be updated from time to time to reflect PGE’s criteria from its latest Commission accepted renewable request for proposals.