FFDC Act definition

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

  • Scientists in ORA’s 13 laboratories typically have analyzed more than 41,000 product samples each year to determine their adherence to the FDA’s standards.Section 516 of the FFDC Act gives FDA the authority to ban devices that present substantial deception or unreasonable and substantial risk of illness or injury.

  • Within 60 days, FDA will render a decision classifying the device according to criteria in 513(a)(1) of FFDC Act.

  • Elder, Tradingem k bohatství, Tetčice, Impossible, s.r.o., 2006, p.300.[4] M.

  • Section 519(a) of the FFDC Act as amended by the SMDA of 1990 required FDA to establish a system for monitoring and tracking serious adverse events that resulted from the use or misuse of medical devices.

  • 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.

  • FDA aims to review most special 510(k)s in 30 days.Under the FFDC Act, first-of-a-kind devices lacking a legally marketed predicate would automatically be designated Class III.

  • New devices which are not classified as Class I or II by another means, are automatically designated as Class III unless the manufacturer files a request or petition for reclassification under Section 513(f)(2) of the FFDC Act (See also 21 CFR§ 860.3(c)(3)).

  • On occasion, District compliance units may initiate case development activities and may issue investigative assignments whenever review of the inspection report raises the possibility of severe violations of the FFD&C Act or other Federal statutes.

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

  • Preclinical data is almost never required for Class I and II devices, or IVDs. For both drugs and devices, valid scientific evidence is required to meet a threshold for “safety” and “effectiveness.”46 FDAMA modified FFDC Act requirements from two to one adequate and well-controlled study, and also permitted use of surrogate endpoints for approval rather than clinical endpoints.


More Definitions of FFDC Act

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

  • FD&C Act means the U.S. Federal Food, Drug and Cosmetic Act, as amended, and the regulations promulgated thereunder.

  • 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, and the rules and regulations promulgated thereunder.

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

  • New Drug Application means a New Drug Application filed with the FDA in accordance with Applicable Law.

  • 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.

  • 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 as may be amended from time to time;

  • Prescription drug order means a lawful order of a practitioner for a drug or device for a specific patient that is communicated to a pharmacist.

  • Drug Approval Application means, with respect to a Licensed Product in the Territory, an application for Regulatory Approval for such product in a country in the Territory. For purposes of clarity, Drug Approval Application shall include, without limitation, (a) an NDA or BLA (for U.S.) or MAA (for Europe); (b) a counterpart of an NDA, BLA or MAA in any country or region in the Territory; and (c) all supplements (including supplemental applications such as sNDAs) and amendments to the foregoing.

  • 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 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;

  • MHLW means the Ministry of Health, Labour and Welfare of Japan, or the successor 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.