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.

FDA Standards means the Act, the establishment license requirements and the Current Good Manufacturing Practice regulations of the FDA applicable to the Royalty-Bearing Products in question or, with respect to the Royalty-Bearing Products, any manufacturing facility at which such Royalty-Bearing Products are manufactured by or for RPPI, and all relevant guidelines of the FDA.

Examples of FDA Standards in a sentence

• CytRx warrants that each shipment of the Copolymer shall be manufactured, temporarily stored, packaged, labeled, and controlled by CytRx in accordance with the Specifications, the Manufacturing Procedures and applicable FDA Standards.

• CytRx will maintain the manufacturing, production and control records for the Copolymer for the periods required by applicable FDA Standards and, in any event, will provide Vaxcel the opportunity to take possession of such records before they are destroyed.

• In order to ascertain on a preliminary basis the degree of ▇▇▇▇▇'▇ compliance with FDA standards, CEPHALON and ▇▇▇▇▇ shall agree on a consultant who will conduct an audit of the Manufacturing Facility to ensure its compliance with Good Manufacturing Practices and other applicable FDA Standards.

• In case the opinions of CEPHALON and ▇▇▇▇▇ may differ on the conformity or nonconformity of the product to Specifications or FDA Standards, the parties shall meet in order to settle the difference amicably.

• The Manufacturing Facility will be qualified as a Good Manufacturing Practice Facility under the FDA Standards at the time of the first production of Compound under this Agreement for clinical purposes.

• If, within thirty (30) days of CEPHALON's receipt of any quantity of the Compound, CEPHALON does not notify ▇▇▇▇▇ that the relevant quantity does not comply with the Specifications or FDA Standards therefor and submit a sample thereof, that quantity shall be deemed to comply in all respects with the Specifications and FDA Standards therefor and CEPHALON shall have no further right to reject the same.

• Wats▇▇ ▇▇▇ll, and shall cause its Affiliates to, comply with applicable foreign, federal, state and local laws, rules and regulations in distributing, marketing, promoting, advertising, selling, storing and packaging the Royalty-Bearing Products, including without limitation all FDA Standards and all applicable portions of the Regulatory Approvals for the Royalty-Bearing Products.

• If CEPHALON does notify ▇▇▇▇▇ within such thirty (30) day period that the Compound does not comply with the Specifications or FDA Standards and does submit a sample thereof, ▇▇▇▇▇ shall check the conformity to the Specifications and FDA Standards of such sample.

• Such inspection shall be conducted at RPRPI's sole cost and expense in a manner so as reasonably to minimize disruption of Wats▇▇'▇ ▇▇▇iness operations, provided that Wats▇▇ ▇▇▇ll reimburse RPRPI for such costs if such inspection reveals a material non-compliance with Product Specifications, FDA Standards or any applicable law.

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.

FDA Standards. ’ means technical speci-

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."

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