FDA Section definition

FDA Section means Section 4.16, other than clause (a) of such Section.

Examples of FDA Section in a sentence

  • Subtitle P—Improving Scientific Expertise and Outreach at FDA Section 2281.

  • Exporting forest products without an export permit from FDA (Section 13.8(a)).

  • On information and belief, from the time Hikma submitted ANDA No. 209457 to FDA in September 2016 and until Hikma submitted to FDA Section viii statements with respect to the Asserted Patents, the proposed label for Hikma’s icosapent ethyl capsules prepared by Hikma contained the CV Limitation of Use.

  • Each session may tune the parameters of GC activity—such as frequency and du- ration of collection slices—in order to trade off responsiveness against overhead.3In its current incarnation, RCANE schedules link bandwidth and buffering at a given node.

  • This conclusion should contribute to the mainstreaming of persons with disabilities in the work of UNHCR.

  • FDA, Section 351, Public Health Service (PHS) Act 42 U.S.Code §262.

  • COMMUNITY FILES APPLICATION FOR AUTHORIZED FOREST COMMUNITY STATUS OverviewUnder the CRL Regulation, communities interested in forming an AFC must submit a letter of application to the FDA (Section 2.2) together with a non-refundable application fee of $250 (Section 2.4).

  • We revised it from 127,925 to 68,566 establishments due to double counting error discovered earlier in the PRIA estimates.• We updated our estimates of costs to foreign facilities based on additional exemptions of firms granted by FDA (Section II.

  • Cross contamination prevention shall be in accordance with (FDA Section 3-302.11).

  • According to the FDA, Section 510(k) of the Food, Drug, and Cosmetic Act requiresdevice manufacturers to notify the FDA of their intent to market a medical device at least 90 days in advance.

Related to FDA Section

  • Tomographic section means the volume of an object whose x-ray attenuation properties are imaged in a tomogram.

  • Line section means either that portion of an EDU's electric system connected to a customer bounded by automatic sectionalizing devices, the end of the distribution line, or a line segment identified as appropriate for study by a utility engineer.

  • Description Section means the section on page one of the Certificate describing the Company's operations and the

  • Permitted Section 5(d) Communication means the Section 5(d) Written Communication(s) and Marketing Materials listed on Schedule C attached hereto. All references in this Agreement to the Registration Statement, the Preliminary Prospectus, any preliminary prospectus, the Base Prospectus and the Prospectus shall include the documents incorporated or deemed to be incorporated by reference therein. All references in this Agreement to financial statements and schedules and other information which are “contained,” “included” or “stated” in, or “part of” the Registration Statement, the Rule 462(b) Registration Statement, the Preliminary Prospectus, any preliminary prospectus, the Base Prospectus, the Time of Sale Prospectus or the Prospectus, and all other references of like import, shall be deemed to mean and include all such financial statements and schedules and other information which is or is deemed to be incorporated by reference in the Registration Statement, the Rule 462(b) Registration Statement, the Preliminary Prospectus, any preliminary prospectus, the Base Prospectus, the Time of Sale Prospectus or the Prospectus, as the case may be. All references in this Agreement to amendments or supplements to the Registration Statement, the Preliminary Prospectus, any preliminary prospectus, the Base Prospectus, the Time of Sale Prospectus or the Prospectus shall be deemed to mean and include the filing of any document under the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder (collectively, the “Exchange Act”) that is or is deemed to be incorporated by reference in the Registration Statement, the Preliminary Prospectus, any preliminary prospectus, the Base Prospectus, or the Prospectus, as the case may be. All references in this Agreement to (i) the Registration Statement, the Preliminary Prospectus, any preliminary prospectus, the Base Prospectus or the Prospectus, any amendments or supplements to any of the foregoing, or any free writing prospectus, shall include any copy thereof filed with the Commission pursuant to its Electronic Data Gathering, Analysis and Retrieval System (“XXXXX”) and (ii) the Prospectus shall be deemed to include any “electronic Prospectus” provided for use in connection with the offering of the Offered Shares as contemplated by Section 3(n) of this Agreement. The Company hereby confirms its agreements with the Underwriters as follows:

  • Non-Section 423 Component means those Offerings under the Plan, together with the sub-plans, appendices, rules or procedures, if any, adopted by the Administrator as a part of this Plan, in each case, pursuant to which rights to purchase Shares during an Offering Period may be granted to Eligible Employees that need not satisfy the requirements for rights to purchase Shares granted pursuant to an “employee stock purchase plan” that are set forth under Section 423 of the Code.

  • Section means a section of the Act.

  • Sub-Sector refers to the specific sector in which the reservation is taken;

  • Sections “Subsections”, “Paragraphs”, and other subdivisions without reference to a document are to designated Articles, Sections, Subsections, Paragraphs and other subdivisions of this Agreement;

  • Initial Response means the first contact by a Support Representative after the incident has been logged and a ticket generated. This may include an automated email response depending on when the incident is first communicated.

  • PQQ Response means the response submitted by the Supplier to the pre-qualification questionnaire issued by the Authority on 06/03/2012;

  • Nominal tomographic section thickness means the full width at half-maximum of the sensitivity profile taken at the center of the cross-sectional volume over which x-ray transmission data are collected.

  • Official responsibility means administrative or operating authority, whether intermediate or final, to initiate, approve, disapprove or otherwise affect a procurement transaction, or any claim resulting therefrom.

  • Remedial response means a measure to stop and correct prohibited conduct, prevent prohibited conduct from recurring, and protect, support, and intervene on behalf of a student who is the target or victim of prohibited conduct.

  • designated sector means a sector, sub-sector or industry that has been designated by the Department of Trade and Industry in line with national development and industrial policies for local production, where only locally produced services, works or goods or locally manufactured goods meet the stipulated minimum threshold for local production and content;

  • Public Sector Entity means a non-commercial administrative body responsible to central governments, regional governments or local authorities, or to authorities that exercise the same responsibilities as regional governments and local authorities, or a non-commercial undertaking that is owned by or set up and sponsored by central governments, regional governments or local authorities, and that has explicit guarantee arrangements, and may include self-administered bodies governed by law that are under public supervision;

  • Short-Term Deferral Period means the period ending on the later of the 15th day of the third month following the end of the Executive’s tax year in which the separation from service occurs and the 15th day of the third month following the end of the Company’s tax year in which the separation from service occurs; and

  • Safe Drinking Water Act means Tit. XIV of the federal Public Health Service Act, commonly known as the “Safe Drinking Water Act”, 42 U.S.C. §300f et seq., as amended by the Safe Drinking Water Amendments of 1996, Pub. L. No. 104-182, as amended.

  • Public Sector means an employing authority as defined in s5 of the Public Sector Management Act 1994.

  • Treasury Regulation means the United States Treasury regulations promulgated under the Code.

  • Nationally recognized testing laboratory means any testing laboratory recognized by the accreditation program of the U.S. department of labor occupational safety and health administration.

  • subheading means the first six-digits in the tariff classification number under the Harmonized System.

  • Insecticide means a pesticide product that is designed for use against insects or other arthropods, but excluding products that are:

  • NZOC Nomination and Selection Regulation means the regulation of NZOC relation to the nomination and selection Process for all Olympic and Commonwealth games, including the Games.

  • U.S. Treasury Regulations means the Treasury regulations of the Code. Reference to a specific Treasury Regulation or Section of the Code shall include such Treasury Regulation or Section, any valid regulation promulgated under such Section, and any comparable provision of any future legislation or regulation amending, supplementing or superseding such Section or regulation.

  • Section 338 Forms means all returns, documents, statements, and other forms that are required to be submitted to any federal, state, local or foreign Taxing authority in connection with a Section 338(h)(10) Election, including, without limitation, any "statement of Section 338 Election" and IRS Form 8023 (together with any schedules or attachments thereto) that are required pursuant to Treasury regulations.

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