§ 330.10 Procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded, and for establishing monographs
§ 330.11 NDA deviations from applicable monograph
§ 330.12 Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI)
§ 330.13 Conditions for marketing ingredients recommended for over-the-counter (OTC) use under the OTC drug review
§ 330.14 Additional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded
§ 330.15 Timelines for FDA review and action on time and extent applications and safety and effectiveness data submissions

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Terms Used In CFR > Title 21 > Chapter I > Subchapter D > Part 330 > Subpart B - Administrative Procedures

  • Affidavit: A written statement of facts confirmed by the oath of the party making it, before a notary or officer having authority to administer oaths.
  • Amendment: A proposal to alter the text of a pending bill or other measure by striking out some of it, by inserting new language, or both. Before an amendment becomes part of the measure, thelegislature must agree to it.
  • Appeal: A request made after a trial, asking another court (usually the court of appeals) to decide whether the trial was conducted properly. To make such a request is "to appeal" or "to take an appeal." One who appeals is called the appellant.
  • Appellate: About appeals; an appellate court has the power to review the judgement of another lower court or tribunal.
  • Bequest: Property gifted by will.
  • Decedent: A deceased person.
  • Docket: A log containing brief entries of court proceedings.
  • Equitable: Pertaining to civil suits in "equity" rather than in "law." In English legal history, the courts of "law" could order the payment of damages and could afford no other remedy. See damages. A separate court of "equity" could order someone to do something or to cease to do something. See, e.g., injunction. In American jurisprudence, the federal courts have both legal and equitable power, but the distinction is still an important one. For example, a trial by jury is normally available in "law" cases but not in "equity" cases. Source: U.S. Courts
  • Escheat: Reversion of real or personal property to the state when 1) a person dies without leaving a will and has no heirs, or 2) when the property (such as a bank account) has been inactive for a certain period of time. Source: OCC
  • Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
  • Forbearance: A means of handling a delinquent loan. A
  • Intestate: Dying without leaving a will.
  • Legatee: A beneficiary of a decedent
  • Litigation: A case, controversy, or lawsuit. Participants (plaintiffs and defendants) in lawsuits are called litigants.
  • Pleadings: Written statements of the parties in a civil case of their positions. In the federal courts, the principal pleadings are the complaint and the answer.
  • Probate: Proving a will
  • Real property: Land, and all immovable fixtures erected on, growing on, or affixed to the land.
  • Service of process: The service of writs or summonses to the appropriate party.
  • Statute: A law passed by a legislature.