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.
Sample 1Sample 2Sample 3
FD & C Act means the United States Federal Food, Drug and Cosmetic Act, as amended.
Sample 1Sample 2

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)].

  • Out of the action a youth environmental movement emerge carrying out yearly youth camps called Ecotopia from 1989 and on- wards and bike tours across Europe.

  • The latter mechanism is particularly important for binary blends since it describes the influence of fast relaxation of shorter chains on the relaxation of longer chains18-20.

  • You must comply with all the FD & C Act’s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the FD & C Act); 21 CFR 1000-1050.

  • Third party suppliers reserve the right to change, modify or cancel any offers without notice.

  • Complete: Introduction to the FD & C Act, web based training module.

  • 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.

  • 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.

  • Generally, once Neurontin was approved by the FDA for adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults with epilepsy, physicians could, using their independent and untainted medical judgment, prescribe the drug for any medical condition as to which the doctor believed the drug was beneficial for the patient without violating the FD & C Act.

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 U.S. Federal Food, Drug and Cosmetic Act, as amended, and the regulations promulgated thereunder.

  • POPI Act means the Protection of Personal Information Act 4 of 2013 as may be amended from time to time;

  • 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, and the rules and regulations promulgated thereunder.

  • BC Act means the Securities Act (British Columbia), the regulations and rules made thereunder and all administrative policy statements, blanket orders, notices, directions and rulings issued or adopted by the British Columbia Securities Commission, all as amended;

  • 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 Regulation of Investigatory Powers 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 means a New Drug Application filed with the FDA in accordance with Applicable Law.

  • FDI Act means the Federal Deposit Insurance Act and the regulations promulgated thereunder.

  • 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;