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.
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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.
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FDA Requirements is defined in Section 4.32.
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Examples of FDA Requirements in a sentence

  • This policy meets the requirements of and responsibilities for compliance with (1) regulations pertaining to federally-funded research (i.e., the “PHS Regulations,” defined below); (2) accreditation standards of the Association for the Accreditation of Human Research Protection Programs (AAHRPP); and (3) FDA Requirements for Financial Disclosure by Clinical Investigators (Title 21 CFR Part 54).

  • FDA Requirements The Food and Drug Administration ensures that products are labeled properly and in a manner that will not mislead the consumer.

  • Waiver of Certain FDA Requirements I am waiving applicable current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with respect to the design, manufacture, packaging, labeling, storage, and distribution of the authorized respirators that are used in accordance with this EUA.

  • The mission recognized substantial efforts made by FNML in rendering the SIMES operational.

  • We Are Subject to Numerous Government Regulations in Addition to FDA Requirements, Which Could Increase Our Costs or Affect Our Operations.In addition to FDA and other regulations described previously, the regulations in some states may restrict our ability to sell products in those states.

  • ECOG Protocol Management⚫ FDA Requirements: IRB must know who will conduct consent process.

  • Browneed to contaminated Chinese food exports.The conference, US FDA Requirements for Food Products Exported to the US, took place November 10–12 at the Jinan Conference Center in Jinan, the capital ofPuppets for PeaceCarrying puppets, a contingent rep- resenting Queens College crossed the Brooklyn Bridge on October 2 (the anniversary of Gandhi’s birth) as part of the World March for Peaceand Non-Violence.

  • FDA Requirements ( Single Patient IND) Additional Clarification IRB Process for Emergency Use/Single Patient IND: 1.

  • Therefore “[t]he centerpiece of risk management for prescription drugs generally is the labeling which reflects thorough FDA review of the pertinent scien- tific evidence and communicates to health care prac- titioners the agency’s formal, authoritative conclu- sions regarding the conditions under which the product can be used safely and effectively.” FDA, Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, 71 Fed.

  • FDA Requirements for Investigators who are also Considered Sponsors of New Drugs:Please review the federal regulations before performing any sponsor duties.


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 Table of Contents 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.
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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.

  • Safety Requirements means Prudent Electrical Practices, CPUC General Order No. 167, Contractor Safety Program Requirements, and all applicable requirements of Law, PG&E, the Utility Distribution Company, the Transmission Provider, Governmental Approvals, the CAISO, CARB, NERC and WECC.

  • Design requirements means the written description of the infrastructure facility to be procured pursuant to this article, including:

  • Project Requirements means the statement included in the Request for Proposal detailing the technical and other requirements of Canada which are to be met by the successful Bidder, and which are to be addressed in the Bid;

  • Technical Requirements means the Technical Requirements in Section VII of the tendering documents.

  • Privacy Requirements shall have the meaning set forth in Section 3.19.

  • Operational requirements means the need to ensure that the Agency is to be operated as effectively, efficiently and economically as possible.

  • Federal safety requirements means applicable provisions of 49 U.S.C. § 30101 et seq. and all

  • Environmental, Health, and Safety Requirements means all federal, state, local and foreign statutes, regulations, ordinances and other provisions having the force or effect of law, all judicial and administrative orders and determinations, all contractual obligations and all common law concerning public health and safety, worker health and safety, and pollution or protection of the environment, including without limitation all those relating to the presence, use, production, generation, handling, transportation, treatment, storage, disposal, distribution, labeling, testing, processing, discharge, release, threatened release, control, or cleanup of any hazardous materials, substances or wastes, chemical substances or mixtures, pesticides, pollutants, contaminants, toxic chemicals, petroleum products or byproducts, asbestos, polychlorinated biphenyls, noise or radiation, each as amended and as now or hereafter in effect.

  • Requirements means and include schedules, details, description, statement of technical data, performance characteristics, standards (Indian as well as International) as applicable and specified in the Contract.

  • Risk Retention Requirements means the credit risk retention requirements of Section 15G of the Exchange Act (15 U.S.C. §78o-11), as added by Section 941 of the Xxxx-Xxxxx Xxxx Street Reform and Consumer Protection Act.

  • Environmental and Safety Requirements means all federal, state, local and foreign statutes, regulations, ordinances and similar provisions having the force or effect of law, all judicial and administrative orders and determinations, all contractual obligations and all common law concerning public health and safety, worker health and safety and pollution or protection of the environment, including all such standards of conduct and bases of obligations relating to the presence, use, production, generation, handling, transport, treatment, storage, disposal, distribution, labeling, testing, processing, discharge, release, threatened release, control, or cleanup of any hazardous materials, substances or wastes, chemical substances or mixtures, pesticides, pollutants, contaminants, toxic chemicals, petroleum products or by-products, asbestos, polychlorinated biphenyls (or PCBs), noise or radiation.

  • Listing Requirements means the Main Market Listing Requirements of Bursa Securities.

  • Storage Injection Requirements means all volumes required by the Seller for injection into underground storage, including cushion gas, and for liquification, including fuel used for injection and in liquification plants, or for such other storage projects that may be developed expressly for the protection of supply to high priority users.

  • Authority Requirements means the operational requirements, functions and characteristics of the Framework set out in Schedule 1 (Statement of Requirements)

  • Data Protection Requirements means all Requirements of Law, to the extent applicable to the items and services provided by the Borrower and each Restricted Subsidiary, relating to the privacy and security of information technology assets and equipment, computers, systems, networks, hardware, software, websites, applications, and databases and personal, personally identifiable, sensitive, confidential or regulated data and, in each case, to the protection thereof from unauthorized use, access, misappropriation or modification.

  • Applicable Technical Requirements and Standards means those certain technical requirements and standards applicable to interconnections of generation and/or transmission facilities with the facilities of an Interconnected Transmission Owner or, as the case may be and to the extent applicable, of an Electric Distributor, as published by Transmission Provider in a PJM Manual provided, however, that, with respect to any generation facilities with maximum generating capacity of 2 MW or less (synchronous) or 5 MW or less (inverter-based) for which the Interconnection Customer executes a Construction Service Agreement or Interconnection Service Agreement on or after March 19, 2005, “Applicable Technical Requirements and Standards” shall refer to the “PJM Small Generator Interconnection Applicable Technical Requirements and Standards.” All Applicable Technical Requirements and Standards shall be publicly available through postings on Transmission Provider’s internet website.

  • End Client Requirements means the specific requirements of the End Client, as notified to the Supplier in writing;

  • Reporting Requirements As defined in Section 11.12.

  • MREL Requirement means the minimum requirement for own funds and eligible liabilities which is or, as the case may be, will be applicable to the Issuer;

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • Maintenance Requirements shall have the meaning set forth in Clause 14.2;