FDA Rules definition

FDA Rules means all FDA rules, regulations and guidances as amended from time to time.
View Source
FDA Rules is defined in Section 5.12.1.
View Source
FDA Rules means any and all applicable laws, statutes, rules, regulations, standards, policies, orders or other requirements promulgated or subject to enforcement, regulation or administration by the United States Food and Drug Administration (the “FDA”), all as amended or modified from time to time, and includes, but is not limited to, current Good Manufacturing Practice regulations of the FDA as set forth in Title 21 of the U.S. Code of Federal Regulations §§ 210 and 211 (“cGMPs”).
View Source

Examples of FDA Rules in a sentence

  • A Wellness Advisor must adhere to all appropriate FDA Rules and Guidelines.

  • Organichem shall isolate and fully characterize all known or suspected impurities for the API and provide samples of all impurities to Purepac in a timely manner to prevent delay of the submission of the Product ANDAs. For the purposes of this section, all known or suspected impurities shall be defined as those impurities that are determined to be present in accordance with FDA Rules and as specified from time to time in the USP.

  • Until the transfer, assignment and/or reissuance (as applicable) of each Business Permit occurs, Seller agrees to comply with the FDA Rules applicable to the holder such Business Permit.

  • Except as may otherwise be agreed, ONXEO shall comply with all regulatory requirements with respect to the Product imposed by applicable law upon ONXEO as the manufacturer of such Product, including without limitation the FDA Rules.

  • The Seller has not used the services of any debarred person under the FDA Rules in connection with the MACI Clinical Trials or related activities that would be used for submission of any FDA applications.

  • The Third Party Manufacturer shall perform analytical testing of each manufactured batch of the Product to be delivered to DARA, using the regulatory approved analytical methods and the Specifications, to verify that it meets its release Specifications, as required by the FDA Rules prior to release of each batch of such Product.

  • Organichem shall at all times maintain its facility for the production of API in compliance with cGMP, the FD&C Act, all FDA Rules and the DMFs. Organichem shall at all times manufacture API in compliance with cGMP, the FD&C Act, all FDA Rules and the DMFs.

  • The cost of DARA-specific Required Manufacturing Changes shall be borne by DARA to the extent that such Required Manufacturing Changes are being required as a result of changes in the FDA Rules, any other laws, rules and regulations or conditions affecting the Territory only and no other market.

  • Additionally, each batch of the Product delivered by ONXEO to DARA shall be accompanied by batch records and a certificate of conformity (the “Certificate of Conformity”) which certifies that the batch was manufactured in conformity with the FDA Rules and manufacturing processes set forth in the NDA.

  • ONXEO represents and warrants that the Product delivered hereunder will (i) be manufactured by ONXEO in accordance with all applicable Regulatory Approvals for such Product, the FDA Rules and with current GMP and other applicable rules and regulations of any applicable Regulatory Authority, and (ii) conform to the applicable Specifications for such Product at the time of delivery to DARA.


More Definitions of FDA Rules

FDA Rules shall have the meaning assigned to that term in Section 4.24 hereof.
View Source

Related to FDA Rules

  • M&A Rules means the Rules on Mergers and Acquisitions of Domestic Enterprises by Foreign Investors jointly promulgated by the Ministry of Commerce, the State Assets Supervision and Administration Commission, the State Administration of Taxation, the State Administration of Industry and Commerce, China Securities Regulatory Commission (the “CSRC”) and the State Administration of Foreign Exchange of the PRC on August 8, 2006 and became effective on September 8, 2006, as amended by the Ministry of Commerce on June 22, 2009.

  • PRA Rules means the Rules included within the PRA handbook issued by the PRA.

  • FCA Rules means the Rules included within the FCA Handbook issued by the FCA.

  • HIPAA Rules means the Privacy, Security, Breach Notification, and Enforcement Rules at 45 CFR Part 160 and Part 164.

  • PPB Rules means the rules of the Procurement Policy Board as set forth in Title 9 of the Rules of the City of New York (“RCNY”), § 1-01 et seq.