Mode of action definition

Mode of action or "MOA" means the sequence of key events following pollutant or chemical exposure upon which the toxic outcome depends.
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Mode of action is defined as “the means by which a product achieves its intended therapeutic effect or action.” 21 C.F.R. § 3.2(k). A product may have a drug, biological product, or device mode of action. Because a combination product is comprised of more than one type of regulated article, and each constituent part contributes a mode of action, a combination product will typically have more than mode of action. PMOA is defined as “the single mode of action of a combination product that provides the most important therapeutic action of the combination product. The most important therapeutic action is the mode of action that is expected to make the greatest contribution to the overall intended therapeutic effects of the combination product.” Id. § 3.2(m). When FDA cannot determine with reasonable certainty which mode of action is the PMOA, the first tier of the two-tiered assignment algorithm provides that FDA “will assign the combination product to the agency component that regulates other combination products that present similar questions of safety and effectiveness with regard to the combination product as a whole.” Id. § 3.4(b). When no combination products present similar questions of safety and effectiveness regarding the combination product as a whole, “the agency will assign the combination product to the agency component with the most expertise related to the most significant safety and effectiveness questions presented by the combination product.” Id.
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Mode of action means the mechanism by which a Product is understood to work using a biologic targeting mechanism to deliver toxin to diseased cells;
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Examples of Mode of action in a sentence

  • All the informants interviewed in the first stage of data collection had either heard of or watched Goo/Cho videos.

  • Mode of action and application of Scorpion primers to mutation detection.

  • Tetracycline antibiotics: Mode of action, applications, molecular biology, and epidemiology of bacterial resistance.

  • Chopra I, Roberts M (2001) Tetracycline antibiotics: Mode of action, applications, molecular biology, and epidemiology of bacterial resistance.

  • Mode of action of nintedanib in the treatment of idiopathic pulmonary fibrosis.

  • Mode of action of the leukotriene synthesis (FLAP) inhibitor BAY X 1005: implications for biological regulation of 5-lipoxygenase.

  • Kepplinger et al., Mode of action and heterologous expression of the natural product antibiotic vancoresmycin.

  • Mode of action of Bacillus thuringiensis Cry and Cyt toxins and their potential for insect control.

  • Mode of action in relevance of rodent liver tumors to human cancer risk.

  • Mode of action of abatacept in rheumatoid arthritis patients having failed tumour necrosis factor blockade: a histological, gene expression and dynamic magnetic resonance imaging pilot study.


More Definitions of Mode of action

Mode of action means the mechanism by which a chemical produces an effect on
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Related to Mode of action

  • Notice of Action shall have the meaning set forth in Section 7.1C.

  • Causes of Action means any claims, interests, damages, remedies, causes of action, demands, rights, actions, suits, obligations, liabilities, accounts, defenses, offsets, powers, privileges, licenses, liens, indemnities, guaranties, and franchises of any kind or character whatsoever, whether known or unknown, foreseen or unforeseen, existing or hereinafter arising, contingent or non-contingent, liquidated or unliquidated, secured or unsecured, assertable, directly or derivatively, matured or unmatured, suspected or unsuspected, in contract, tort, law, equity, or otherwise. Causes of Action also include: (a) all rights of setoff, counterclaim, or recoupment and claims under contracts or for breaches of duties imposed by law; (b) the right to object to or otherwise contest Claims or Interests; (c) claims pursuant to sections 362, 510, 542, 543, 544 through 550, or 553 of the Bankruptcy Code; and (d) such claims and defenses as fraud, mistake, duress, and usury, and any other defenses set forth in section 558 of the Bankruptcy Code.

  • Lawsuit means any lawsuit, arbitration or other dispute resolution filed by either party herein pertaining to any of this Warrant, the Facility Agreement and the Registration Rights Agreement.

  • Civil action means all suits or claims of a civil nature in a state or federal court, whether cognizable as cases at law or in equity or admiralty. "Civil action" does not include any of the following:

  • Claim means any claim, action, cause of action, demand, lawsuit, arbitration, inquiry, audit, notice of violation, proceeding, litigation, citation, summons, subpoena, or investigation of any nature, whether civil, criminal, administrative, regulatory or other, and whether at law, in equity or otherwise brought against an Indemnified Person.

  • Complaint means any dissatisfaction expressed by a Complainant orally or in writing to HMO about any aspect of HMO’s operation, including, but not limited to:

  • Plaintiffs means Xxxx XxXxxxxxxxx, Xxxxxx Xxxxxxx, and Xxxx Xxxxxxxxx.

  • Released PAGA Claims means the claims being released as described in Paragraph 6.2 below.

  • Legal Action means and includes any claim, counterclaim, demand, action, suit, counterclaim, arbitration, inquiry, proceeding or investigation before any

  • Released Plaintiff Claims means any and all manner of claims, demands, rights, liabilities, losses, obligations, duties, damages, costs, debts, expenses, interest, penalties, sanctions, fees, attorneys’ fees, actions, potential actions, causes of action, suits, agreements, judgments, decrees, matters, counterclaims, offsets, issues, and controversies of any kind, nature, or description whatsoever, whether accrued or unaccrued, disclosed or undisclosed, apparent or not apparent, foreseen or unforeseen, matured or not matured, suspected or unsuspected, liquidated or not liquidated, fixed or contingent, whether based on state, local, federal, statutory, regulatory, common, or other law or rule, including known claims and Unknown Claims, that (a) were asserted in the Derivative Matters, or (b) Plaintiffs (individually or derivatively on behalf of AMC) or AMC ever had, now have, or hereafter can, shall, or may have that, in full or in part, concern, relate to, arise out of, or are in any way connected to the claims, allegations, transactions, facts, circumstances, events, acts, disclosures, statements, representations, omissions, or failures to act alleged, set forth, referred to, or involved in the Derivative Matters. For the avoidance of doubt, the Released Plaintiff Claims shall not include any claims to enforce the Stipulation or the Settlement.

  • Unknown Claims means any Released Plaintiffs’ Claims which any Lead Plaintiff or any other Settlement Class Member does not know or suspect to exist in his, her or its favor at the time of the release of such claims, and any Released Defendants’ Claims which any Defendant or any other Defendants’ Releasee does not know or suspect to exist in his, her, or its favor at the time of the release of such claims, which, if known by him, her or it, might have affected his, her or its decision(s) with respect to this Settlement. With respect to any and all Released Claims, the Parties stipulate and agree that, upon the Effective Date of the Settlement, Lead Plaintiffs and Defendants shall expressly waive, and each of the other Settlement Class Members and each of the other Defendants’ Releasees shall be deemed to have waived, and by operation of the Judgment or the Alternate Judgment, if applicable, shall have expressly waived, any and all provisions, rights, and benefits conferred by any law of any state or territory of the United States, or principle of common law or foreign law, which is similar, comparable, or equivalent to California Civil Code §1542, which provides:

  • Defendant means any party named as a defendant in the Action at any time up to and including the date when the Court has entered a final order certifying the Settlement Class described in Paragraph 12 and approving this Agreement under Federal Rule of Civil Procedure (“Rule”) 23(e).

  • Released Claims means all Released Defendants’ Claims and all Released Plaintiffs’ Claims.