FFDC Act definition

FFDC Act means the Federal Food, Drug and Cosmetic Act, as amended from time to time, and any successor statute.
Sample 1Sample 2Sample 3
FFDC Act means the Federal Food Drug and Cosmetic Act, 21 U.S.C. § 301 et seq.
Sample 1Sample 2
FFDC Act shall have the meaning set forth in Section 4.13(b).
Sample 1

Examples of FFDC Act in a sentence

  • Most importantly, we agree that it is important to ensure that alcoholbeverage producers do not violate the new drug provisions of the FFDC Act when seeking to use specific health claims on alcohol beverage labels.

  • BLP represents and warrants to AHC that at the time of delivery, the Product manufactured and supplied hereunder will conform to the cGMPs and the FFDC Act, and other applicable laws and regulations.

  • Although the FFDC Act gives FDA the authority to impose legal sanctions for not complying with MDR, FDA relies largely on the goodwill and cooperation of all affected groups to accomplish the objectives of the regulation.

  • At least one field density test and one moisture content determination shall be made for each 100 m3 or portion thereof of each classification of compacted fill placed during one shift.At least one particle size analysis and one plasticity index determination shall be made for each 500 m3, except that at least one additional particle size analysis shall be made for each significant change in material being used.

  • The term ‘labeling’ is defined in the FFDC Act as including all printed matter accompanying any article.

  • If FDA determines that a specific health claim is a drug claim that is not in compliance with the requirements of the FFDC Act, TTB will not approve the use of such statement on a label.

  • Section 201(k) of the FFDC Act defines a “label” as a: “display of written, printed, or graphic matter upon the immediate container of any article.” Section 201(m) defines “labeling” as: “all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article” at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.

  • Richmond is also being honored as Irishman of the Year by the Ancient Order of Hibernians on Saturday.

  • This is where neural network technology comes to the help of fuzzy logic, in the form of intelligent systems that are referred to as Fuzzy Neural Networks (FNNs).

  • CNS performed no clinical studies, and proposed that the previously available clinical data with Lioresal supported approval of this NDA (this NDA was submitted under section 505(b)(2) of the FFD&C Act).


More Definitions of FFDC Act

FFDC Act shall have the meaning set forth in paragraph 14 of Exhibit B.
Sample 1
FFDC Act has the meaning set forth in Section 3.20(b)(i).
Sample 1
FFDC Act is defined Section 3.18(b)(1).
Sample 1

Related to FFDC Act

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

  • 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).

  • FMC Act means the Financial Markets Conduct Act 2013.

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

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

  • 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.

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

  • Drug Application means a new drug application, an abbreviated drug application, or a product license application for any Product, as appropriate, as those terms are defined in the FDCA.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

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

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

  • Prescription drug order means an original or new order from a practitioner for drugs, drug-related devices or treatment for a human or animal, including orders issued through collaborative care agreements. Lawful prescriptions result from a valid practitioner-patient relationship, are intended to address a legitimate medical need, and fall within the prescribing practitioner's scope of professional practice;

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale of a Product as a pharmaceutical product in a regulatory jurisdiction.

  • Drug abuse means any pattern of pathological use of drugs that causes impairment in social or occupational functioning, or that produces physiological dependency evidenced by physical tolerance or by physical symptoms when it is withdrawn.

  • Federal Regulations means those federal regulations relating to cable television services, 47 C.F.R. Section 76.1 et seq. (and, to the extent applicable, any other federal rules and regulations relating to cable television, including but not limited to, those described in 47 C.F.R. Section 76.3), or as such regulations may be amended.

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

  • Drug addiction means a disease characterized by a

  • 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.

  • PBR Act means the Plant Breeder’s Rights Xxx 0000 (Cth) 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;

  • MHLW means the Japanese Ministry of Health, Labour and Welfare, and any successor agency thereto.

  • Public health authority means an agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate.

  • Occupational Health and Safety Act means the Occupational Health and Safety Act, 1993 (Act No 85 of 1993);

  • Legend drug or "prescription drug" means any drug or device that has been determined to be unsafe for self- medication or any drug or device that bears or is required to bear the legend:

  • FCC Regulations means the regulations duly and lawfully promulgated by the FCC, as in effect from time to time.