§ 1114.25 Communication between FDA and applicants
§ 1114.27 Review procedure
§ 1114.29 FDA action on an application
§ 1114.31 Issuance of a marketing granted order
§ 1114.33 Issuance of a marketing denial order
§ 1114.35 Withdrawal of a marketing granted order
§ 1114.37 Temporary suspension of a marketing granted order

Terms Used In CFR > Title 21 > Chapter I > Subchapter K > Part 1114 > Subpart C - Fda Review

  • 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.
  • Appraisal: A determination of property value.
  • Complaint: A written statement by the plaintiff stating the wrongs allegedly committed by the defendant.
  • Contract: A legal written agreement that becomes binding when signed.
  • Jurisdiction: (1) The legal authority of a court to hear and decide a case. Concurrent jurisdiction exists when two courts have simultaneous responsibility for the same case. (2) The geographic area over which the court has authority to decide cases.
  • Lawsuit: A legal action started by a plaintiff against a defendant based on a complaint that the defendant failed to perform a legal duty, resulting in harm to the plaintiff.
  • Lease: A contract transferring the use of property or occupancy of land, space, structures, or equipment in consideration of a payment (e.g., rent). Source: OCC
  • Recipient: includes any successor, assignee, or transferee, but does not include the ultimate beneficiary of the assistance. See 28 CFR 42.702
  • Settlement: Parties to a lawsuit resolve their difference without having a trial. Settlements often involve the payment of compensation by one party in satisfaction of the other party's claims.
  • Statute: A law passed by a legislature.
  • Testify: Answer questions in court.