FD & C Act definition

FD & C Act means the United States Federal Food, Drug and Cosmetic Act, as amended, and applicable regulations promulgated thereunder, as amended from time to time.
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Examples of FD & C Act in a sentence

  • Recall type is a designation based on whether the recall is Voluntary, FDA Requested (at the request of the Commissioner or his/her designee), or ordered under section 518(e) of the FD & C Act [21 U.S.C 360h (e)].

  • A medical device notification order is an order issued by FDA requiring notification under section 518(a) of the FD & C Act [21 U.S.C. 360h (a)].

  • All shipments of Active Ingredient shall be accompanied by a packing slip and a Certificate of Analysis which describes the Active Ingredient, states the PO number, confirms that the Active Ingredient conforms in all ways with the Specifications and was manufactured in accordance with cGMP and all other requirements of the FD & C Act and all other Applicable Laws, rules and regulations.

  • In addition, JULPHAR agrees to cooperate with DANCE with respect to obligations to submit or report information relevant to API pursuant to EMA, FDA regulations , the FD & C Act and all other Applicable Laws.

  • The agreement as announced called for antimicrobials used in food packaging to remain at FDA and be regulated as food additives under Section 409 of the FD & C Act.

  • Applicants granted small business waivers for their first application for human drug or biosimilar biological drug products are not required to pay application fees assessed in accordance with FD & C Act, Sections 735, 736, and 744.

  • Ascent represents and warrants that it shall cause all members of the Ascent Sales Force to comply with (i) the applicable laws, rules, regulations and guidelines related to the performance of its obligations hereunder, including, but not limited to the FD & C Act, the PDMA, the Federal and State Anti-Kickback Statutes and AMA Guidelines and (ii) Ascent's obligations under the terms of this Agreement.

  • In addition, AERO PUMP agrees to cooperate with DANCE with respect to obligations to submit or report information relevant to PUMPS pursuant to CFDA, EMA, FDA regulations , the FD & C Act and all other Applicable Laws.

  • Medical devices that have not received marketing clearance under section 510(k) of the FD & C Act are also considered unapproved devices.

  • All shipments of PUMPS shall be accompanied by a packing slip and a Certificate of Analysis which describes the PUMPS, states the PO number, confirms that the PUMPS conforms in all ways with the Specifications and was manufactured in accordance with cGMP and all other requirements of the FD & C Act and all other Applicable Laws, rules and regulations.

Related to FD & C Act

  • FMC Act means the Financial Markets Conduct Act 2013.

  • ACNC Act means the Australian Charities and Not-for-profits Commission Act 2012 (Cth).

  • FD&C Act means the United States Federal Food, Drug and Cosmetic Act, as amended.

  • POPI Act means the Protection of Personal Information Act, 4 of 2013;

  • FW Act means the Fair Work Act 2009, as amended from time to time.

  • FOI Act means the Freedom of Information Act 2000 and any subordinate legislation made under that Act or any code issued pursuant to sections 45 or 46 of that Act or any guidance issued by the Information Commissioner;

  • FDA Act means the U.S. Federal Food, Drug, and Cosmetic Act, as amended.

  • BC Act means the Securities Act (British Columbia);

  • PBR Act means the Plant Breeder’s Rights Xxx 0000 (Cth) as amended from time to time.

  • FFDCA means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).

  • SEBI Act or “Act” means the Securities and Exchange Board of India Act, 1992;

  • FDCA shall have the meaning ascribed to such term in Section 3.1(hh).

  • EP Act means the Environmental Protection Xxx 0000;

  • 2012 Act means the Health and Social Care Act 2012;

  • Federal Reserve Act means the Federal Reserve Act, as amended.

  • CFTC Regulations means the rules and regulations promulgated by the CFTC, as amended.

  • 1990 Act means the Town and Country Planning Act 1990;

  • Foreign Corrupt Practices Act means the Foreign Corrupt Practices Act of the United States, 15 U.S.C. Sections 78a, 78m, 78dd-1, 78dd-2, 78dd-3, and 78ff, as amended, if applicable, or any similar law of the jurisdiction where the Property is located or where the Company or any of its Subsidiaries transacts business or any other jurisdiction, if applicable.

  • 2000 Act means the Local Government Act 2000;

  • Corrupt Act means any offence in respect of corruption or corrupt activities contemplated in the Prevention and Combating of Corrupt Activities Act No. 12 of 2004;

  • Criminal drug statute means a Federal or non-Federal criminal statute involving the manufacture, distribution, dispensing, possession or use of any controlled substance.

  • Regulation CF means Regulation Crowdfunding promulgated under the Securities Act.

  • New Drug Application means a new drug application in the United States for authorization to market a product, as defined in the applicable laws and regulations and submitted to the FDA.

  • FDI Act means the Federal Deposit Insurance Act, as amended or recodified.

  • S.A.F.E. act means the secure and fair enforcement for mortgage licensing act of 2008, Title V of the housing and economic recovery act of 2008 ("HERA"), P.L. 110-289, effective July 30, 2008.

  • ECT Act means the Electronic Communications and Transaction Act No 25 of 2002, as amended;