FDA Standards definition

FDA Standards means technical specifications that have been adopted and published by FDA through the appropriate governance process. FDA standards may apply to terminology, information exchange, engineering or technology specifications, or other technical matters related to information systems. FDA standards often are based on the publications of other federal agencies, or the publications of national or international Standards Development Organizations.
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FDA Standards means the facility license requirements and the Good Manufacturing Practice regulations of the FDA applicable to the Copolymer or the Manufacturing Facility.
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FDA Standards means the Act, the establishment license requirements and the Current Good Manufacturing Practice regulations of the FDA applicable to the Product or, insofar as the Product is concerned, the manufacturing facility of the Designated Manufacturer, and all relevant guidelines of the FDA.
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Examples of FDA Standards in a sentence

  • Canned fruit and vegetable juice must conform to the FDA Standards of Identity.

  • Sweetening ingredients may be any of those permitted in quantities permitted by the FDA Standards of Identity for Fruit Jelly (21 CFR § 150.140).

  • If it is enriched, the item must meet the Food and Drug Administration’s (FDA) Standards of Identity for enriched bread, macaroni and noodle products, rice, or cornmeal.

  • For the government’s purposes, see HEW, FDA, Standards for Institutional Review Boards for Clinical Investigations, 43 Fed Reg 35188 (Aug 8, 1978) (re NIH’s requirements for IRBs).

  • Over her shoulder, he finally notices the teenage soccer girl walking in his direction - still far away.

  • Where applicable, references include the USDA regulations or the FDA Standards of Identity.

  • Prospective FDA Standards for NGS Tests as a Medical DeviceIn July 2016 the FDA issued a draft (i.e., non- binding) guidance for regulatory oversight of NGS sequencing in vitro diagnostics 34.

  • Sweetening ingredients may be any of those permitted in quantities permitted by the FDA Standards of Identity for Fruit Preserves and Jams (21 CFR § 150.160).

  • Reprocessing The University of Iowa Hospitals and Clinics, currently, in (Required) targeted areas may utilize a 3rd party to perform reprocessing following FDA Standards.

  • Clinical monitoring shall have the goal of maintaining serum Lithium levels not to exceed FDA Standards.


More Definitions of FDA Standards

FDA Standards. ’ means technical speci- fications that have been adopted and pub- lished by the FDA through the appropriate governance process. FDA standards may apply to terminology, information exchange, engineering or technology specifications, or other technical matters related to informa- tion systems. FDA standards often are based on the publications of other federal agencies, or the publications of national or inter- national Standards Development Organiza- tions.
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FDA Standards. ’ means technical speci-
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FDA Standards. DHHS Federal Performance Standard 21 CFR 1030.10 . Sanitation Standard: NSF STD NO. 4-1992 - Maintained by UL- File E151488. . FCC Specifications: FCC Part 18. Canadian requirements .. CAN/CSA-C22.2 No. 150-M89
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FDA Standards as used in the Supply Agreement is hereby deleted and the term "Regulatory Standards" is hereby substituted in its place. For purposes of the Supply Agreement, "Regulatory Standards" shall be defined as follows: "the facility license requirements and the Good Manufacturing Practice regulations of the U.S. FDA applicable to the Compound or the Manufacturing Facility (as such terms are defined in the Supply Agreement) and all other laws, rules and regulations applicable to the manufacture, packaging, labelling and shipment of the Compound into the Territory."
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Related to FDA Standards

  • Quality Standards means the quality standards published by BSI British Standards, the National Standards Body of the United Kingdom, the International Organisation for Standardisation or other reputable or equivalent body, (and their successor bodies) that a skilled and experienced operator in the same type of industry or business sector as the Contractor would reasonably and ordinarily be expected to comply with, and as may be further detailed in the Specification.

  • Safety Standards means all laws, union rules and trade or industry custom or codes of any kind whatsoever, in effect from the date of this Agreement through Final Acceptance of the construction work, pertaining to worker safety and accident prevention applicable to the Project and/or the construction work (including, but not limited to, rules, regulations and standards adopted pursuant to the Occupational Safety and Health Act of 1970, as amended from time to time).

  • Technical Standards means the technical standards set out in paragraph 2.5 of the Order Form;

  • Applicable Standards means the requirements and guidelines of NERC, the Applicable Regional Entity, and the Control Area in which the Customer Facility is electrically located; the PJM Manuals; and Applicable Technical Requirements and Standards.

  • Reliability Standards means the criteria, standards, rules and requirements relating to reliability established by a Standards Authority.

  • NERC Reliability Standards means the most recent version of those reliability standards applicable to the Generating Facility, or to the Generator Owner or the Generator Operator with respect to the Generating Facility, that are adopted by the NERC and approved by the applicable regulatory authorities, which are available at xxxx://xxx.xxxx.xxx/files/Reliability_Standards_Complete_Set.pdf, or any successor thereto.

  • Minimum Standards means standards of practice that interpret the legal definition of nursing as well as provide criteria against which violations of the law can be determined.

  • auditing standards means auditing standards as defined in National Instrument 52-107 Acceptable Accounting Principles and Auditing Standards;

  • Service Level Standards has the meaning ascribed thereto in Section 2.1 hereof.

  • Operating Standards shall have the meaning given such term in Section 2.1.

  • Standards means the British or international standards, Authority's internal policies and procedures, Government codes of practice and guidance referred to in Framework Schedule 13 (Standards) together with any other specified policies or procedures identified in Framework Schedule 13 (Standards);

  • Accessibility Standards means accessibility standards and specifications for Texas agency and institution of higher education websites and EIR set forth in 1 TAC Chapter 206 and/or Chapter 213.

  • Pretreatment standards means all applicable Federal rules and regulations implementing Section 307 of the Act, as well as any nonconflicting State or local standards. In cases of conflicting standards or regulations, the more stringent thereof shall be applied.

  • Codes and Standards means all the applicable codes and standards as indicated in the Technical Specification.

  • Water quality standards means provisions of state or federal law which consist of a designated use or uses for the waters of the Commonwealth and water quality criteria for such waters based upon such uses. Water quality standards are to protect the public health or welfare, enhance the quality of water and serve the purposes of the State Water Control Law (§ 62.1-44.2 et seq. of the Code of Virginia) and the federal Clean Water Act (33 USC § 1251 et seq.).

  • Applicable water quality standards means all water quality standards to which a discharge is subject under the federal Clean Water Act and which has been (a) approved or permitted to remain in effect by the Administrator following submission to the Administrator pursuant to Section 303(a) of the Act, or (b) promulgated by the Director pursuant to Section 303(b) or 303(c) of the Act, and standards promulgated under (APCEC) Regulation No. 2, as amended.

  • Benchmarks Regulation means Regulation (EU) 2016/1011 of the European Parliament and of the Council of 8 June 2016 on indices used as benchmarks in financial instruments and financial contracts or to measure the performance of investment funds and amending Directives 2008/48/EC and 2014/17/EU and Regulation (EU) No 596/2014;

  • National Standards means the document entitled “National Standards for the Volatile Organic Compound Content of Canadian Commercial/Industrial Surface Coating Products Automotive Refinishing, October 1998, PN 1288" and published by the Canadian Council of Ministers of the Environment;

  • harmonised standard means harmonised standard as defined in point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012;

  • Standards Board means the Professional Standards Board established pursuant to 14 Del.C. §1201.

  • State minimum standards means minimum requirements

  • Privacy Standards means the standards of the privacy of individually identifiable health information, as pursuant to HIPAA.

  • Design Standards means the standards developed as a requirement of the Programmatic Agreement

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

  • Technical standard means a document that specifies design, predicted performance and operation and maintenance specifications for a material, device or method.

  • Specifications and Standards means the specifications and standards relating to the quality, quantity, capacity and other requirements for the Project Highway, as set forth in Schedule-D, and any modifications thereof, or additions thereto, as included in the design and engineering for the Project Highway submitted by the Contractor to, and expressly approved by, the Authority;