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

  • We see nothing in any of the cases we have cited to so limit the reach of the Declaratory Judgment Act in these circumstances.

  • 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)].

  • 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.

  • All products shall be packed under conditions that meet all the requirements of the FD & C Act, including current CP and/or USDA Sanitation Regulations or other regulator standards for sanitation and for wholesomeness, as applicable.

  • In the approval a new drug, for example, FDA shall consider its safety (Section 505(d) of FD & C Act); In the same Section, FDA shall require the sponsor provides substantial evidence that the drug will have the effect it purports or.

  • Although a physician may prescribe most, but not all, drugs for an off-label use without violating the FD & C Act, a manufacturer may not market or promote it for such unapproved uses.

  • 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.

  • 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.

  • Associate Principal Briggs stated that Cornelius Godfrey of Troy Community Schools is facilitating the Circle Team of staff, administrators, and students at IA East which is meeting every three to four weeks to discuss current issues and bring student voice into conversations.

  • The applicable guideline offense level for Warner-Lambert's violation of 21 U.S.C. §333(a)(2) (which is based upon a prior FD & C Act violation and not an intent to defraud or mislead) is determined under U.S.S.G. § 2N2.1. See U.S.S.G. Appendix A.

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 (21 U.S.C. § 301 et seq.), as amended, and the rules and regulations promulgated thereunder.

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

  • FOI Act means the Freedom of Information Xxx 0000 and any subordinate legislation made under this Act from time to time together with any guidance and/or codes of practice issued by the Information Commissioner in relation to such legislation;

  • 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 Companies 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;

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

  • CER Act means the Canadian Energy Regulator Act (Canada), and regulations thereunder, all as amended or replaced from time to time.

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

  • New Drug Application or “NDA” means a new drug application filed with a Regulatory Authority (not including pricing and reimbursement approval), that is analogous to the new drug application with the United States Food and Drug Administration described in 21 C.F.R. § 314.

  • Federal Clean Air Act means Chapter 85 (§ 7401 et seq.) of Title 42 of the United States Code.

  • 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;

  • HITECH Act means the Health Information Technology for Economic and Clinical Health Act, TitleXIII, Subtitle D, Part 1 & 2 of the American Recovery and Reinvestment Act of 2009.