Boxed Warning definition

Boxed Warning means labeling requirements, as may be required by the FDA as set forth in 21 C.F.R. § 201.57(c)(1).
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Boxed Warning means a contraindication or serious warning required by the FDA to be presented in a box within the approved labeling of a drug product, as set forth in 21 C.F.R. Sections 201.57(a)(4) and 201.57(c)(1). “Business Day” shall mean a day (other than a Saturday or Sunday) on which commercial banks are not authorized or required to close in New York City, Toronto, Canada, or London, England. “Call Option” shall have the meaning set forth in Section 5.05(a). “Call Option Closing Date” shall have the meaning set forth in Section 5.05(a). “Call Price” shall mean, as of any date of determination, an amount sufficient, that, after giving effect to the payment of the Assigned Interests Payments made by the Company to the Purchasers pursuant to Section 2.02(a), (i) the MOIC equals 1.20x, if such date is on or before the one-year anniversary of the Tranche A Funding Date, (ii) the MOIC equals 1.40x, if such date is after the one-year anniversary of the Tranche A Funding Date and on or before the two-year anniversary of the Tranche A Funding Date, (iii) the MOIC equals 1.55x if such date is after the two-year anniversary of the Tranche A Funding Date and on or before the three-year anniversary of the Tranche A Funding Date, and (iv) the MOIC equals 1.75x if such date is after the three-year anniversary of the Tranche A Funding Date. “Capital Lease Obligations” shall mean, as to any Person, the obligations of such Person to pay rent or other amounts under a lease of (or other agreement conveying the right to use) any property by such Person as lessee, which obligations are required to be classified and accounted for as a capital lease or finance lease on a balance sheet of such Person under GAAP, and for the purposes of this Agreement, the amount of such obligations shall be the capitalized amount thereof, determined in accordance with GAAP. “Capital Lease Obligations” shall not include any obligations under a straight-line or operating lease (including any lease that would not have been a capital lease under GAAP prior to giving effect to Accounting Standards Codification 842, Leases). “Change of Control” shall mean an event or series of events (i) as a result of which any “person” or “group” (as such terms are used in Sections 13(d) and 14(d) of the Securities Act, but excluding any of such person or its Subsidiaries, and any Person acting in its capacity as trustee, agent or other fiduciary or administrator of any such Plan) becomes the “beneficial owner”, directly or...
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Boxed Warning means a contraindication or serious warning required by the FDA to be presented in a box within the approved labeling of a drug product, as set forth in 21 C.F.R. Sections 201.57(a)(4) and 201.57(c)(1).
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Examples of Boxed Warning in a sentence

  • The length of HL must be less than or equal to one-half page (the HL Boxed Warning does not count against the one-half page requirement) unless a waiver has been is granted in a previous submission (i.e., the application being reviewed is an efficacy supplement).

  • Pertains to only the following five sections of the FPI: Boxed Warning, Indications and Usage, Dosage and Administration, Contraindications, and Warnings and Precautions.

  • The section headings and subheadings (including title of the Boxed Warning) in the TOC must match the headings and subheadings in the FPI.

  • Use sentence case (combination of uppercase and lowercase letters typical of that used in a sentence) for the information in the Boxed Warning.

  • The HL Boxed Warning does not count against the one-half page requirement.

  • Olanzapine is not approved for the treatment of patients with dementia-related psychosis [see Boxed Warning, Warnings and Precautions (5.1), and Patient Counseling Information (17)].

  • FANAPT and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia [see Boxed Warning].

  • As lower-dose estrogen products are now approved for the treatment of moderate to severe symptoms of VVA due to menopause, some in the scientific/medical community have questioned whether these statements in the Boxed Warning section are applicable in whole or in part to the lower-dose estrogen products.

  • The length of HL must be one-half page or less (the HL Boxed Warning does not count against the one-half page requirement) unless a waiver has been granted in a previous submission (e.g., the application being reviewed is an efficacy supplement).Instructions to complete this item: If the length of the HL is one-half page or less, then select “YES” in the drop-down menu because this item meets the requirement.

  • Quetiapine is not approved for the treatment of patients with dementia-related psychosis [see Boxed Warning].


More Definitions of Boxed Warning

Boxed Warning means any notice required by Health Canada or by any foreign equivalent of such. A Boxed Warning is deemed to be a Circumstance and is subject to the reporting requirements of Clause XII.
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Boxed Warning means a contraindication or serious warning required by the FDA to be presented in a box within the approved labeling of a drug product, as set forth in 21 C.F.R. Sections 201.57(a)(4) and 201.57(c)(1). Tranche C Term Loans Lenders and their respective Applicable Commitments: Lender Applicable Commitment Oaktree-TCDRS Strategic Credit, LLC [***] Oaktree-Xxxxxxx Multi-Strategy, LLC [***] Oaktree-TBMR Strategic Credit Fund C, LLC [***] Oaktree-TBMR Strategic Credit Fund F, LLC [***] Oaktree-TBMR Strategic Credit Fund G, LLC [***]
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Related to Boxed Warning

  • Warning in all capital letters and in bold font. The warning symbol to the left of the word “WARNING:” must be a black exclamation point in a yellow equilateral triangle with a black outline, except if the labeling does not use the color yellow, the symbol may be in black and white. The entire warning shall appear in at least 6-point type and no smaller than the largest type size used for other consumer information on the Products.

  • Signal means any transmission of radio frequency energy or of optical information.

  • Labeling means all labels and other written, printed, or graphic matter on an article or any of its

  • Psychotropic medication means medication the prescribed intent of which is to affect or alter thought processes, mood, or behavior including but not limited to anti-psychotic, antidepressant, anxiolytic (anti-anxiety), and behavior medications. The classification of a medication depends upon its stated, intended effect when prescribed.

  • labelling means any words, particulars, trade marks, brand name, pictorial matter or symbol relating to a food and placed on any packaging, document, notice, label, ring or collar accompanying or referring to such food;

  • Sensor means any measurement device that is not part of the vehicle itself but installed to determine parameters other than the concentration of gaseous and particle pollutants and the exhaust mass flow.

  • Sterilization means the procedure that kills all microorganisms, including their spores.

  • Medication means any drug, chemical, compound, suspension, or preparation in suitable form for use as a curative or remedial substance taken either internally or externally by any person.

  • FedRAMP means the Federal Risk and Authorization Management Program (see xxx.xxxxxxx.xxx), which is an assessment and authorization process that federal government agencies have been directed to use to ensure security is in place when accessing Cloud computing products and services.

  • Cannabis products means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • Substance abuse treatment means outpatient or inpatient services or participation in Alcoholics Anonymous or a similar program.

  • Prescription medication means any medication that requires a physician prescription before it may be obtained from a pharmacist.

  • Cannabis product means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • Carriage means the whole or any part of the operations and services undertaken by the Carrier in respect of the Goods covered by this Bill of Lading.

  • Encapsulation means the application of an encapsulant.

  • Sampler means a person who is employed by or is an owner of a licensed laboratory, grower, or processor and is authorized by that employer to collect samples in accordance with the testing laboratory's standard operating procedures and these Rules.

  • Spectrum Compatibility means the capability of two (2) copper loop transmission system technologies to coexist in the same cable without service degradation and to operate satisfactorily in the presence of cross talk noise from each other. Spectrum compatibility is defined on a per twisted pair basis for specific well-defined transmission systems. For the purposes of issues regarding Spectrum Compatibility, service degradation means the failure to meet the Bit Error Ratio (BER) and Signal-to-Noise Ratio (SNR) margin requirements defined for the specific transmission system for all Loop lengths, model Loops, or loss values within the requirements for the specific transmission system.

  • Supported Wage System means the Commonwealth Government system to promote employment for people who cannot work at full Award wages because of a disability as documented in “[Supported Wages System: Guidelines and Assessment Process]”.