§ 360bbb Expanded access to unapproved therapies and diagnostics
§ 360bbb-0 Expanded access policy required for investigational drugs
§ 360bbb-0a Investigational drugs for use by eligible patients
§ 360bbb-1 Dispute resolution
§ 360bbb-2 Classification of products
§ 360bbb-3 Authorization for medical products for use in emergencies
§ 360bbb-3a Emergency use of medical products
§ 360bbb-3b Products held for emergency use
§ 360bbb-3c Expedited development and review of medical products for emergency uses
§ 360bbb-4 Countermeasure development, review, and technical assistance
§ 360bbb-4a Priority review to encourage treatments for agents that present national security threats
§ 360bbb-4b Medical countermeasure master files
§ 360bbb-5 Critical Path Public-Private Partnerships
§ 360bbb-5a Emerging technology program
§ 360bbb-6 Risk communication
§ 360bbb-7 Notification
§ 360bbb-8 Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments
§ 360bbb-8a Optimizing global clinical trials
§ 360bbb-8b Use of clinical investigation data from outside the United States
§ 360bbb-8c Patient participation in medical product discussion
§ 360bbb-8d Notification, nondistribution, and recall of controlled substances

Terms Used In U.S. Code > Title 21 > Chapter 9 > Subchapter V > Part E - General Provisions Relating to Drugs and Devices

  • 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.
  • Appellate: About appeals; an appellate court has the power to review the judgement of another lower court or tribunal.
  • Appropriation: The provision of funds, through an annual appropriations act or a permanent law, for federal agencies to make payments out of the Treasury for specified purposes. The formal federal spending process consists of two sequential steps: authorization
  • Assets: (1) The property comprising the estate of a deceased person, or (2) the property in a trust account.
  • association: when used in reference to a corporation, shall be deemed to embrace the words "successors and assigns of such company or association" in like manner as if these last-named words, or words of similar import, were expressed. See 1 USC 5
  • Cloture: The only procedure by which the Senate can vote to place a time limit on consideration of a bill or other matter, and thereby overcome a filibuster. Under the cloture rule (Rule XXII), the Senate may limit consideration of a pending matter to 30 additional hours, but only by vote of three-fifths of the full Senate, normally 60 votes.
  • Continuance: Putting off of a hearing ot trial until a later time.
  • Contract: A legal written agreement that becomes binding when signed.
  • Corporation: A legal entity owned by the holders of shares of stock that have been issued, and that can own, receive, and transfer property, and carry on business in its own name.
  • county: includes a parish, or any other equivalent subdivision of a State or Territory of the United States. See 1 USC 2
  • Entitlement: A Federal program or provision of law that requires payments to any person or unit of government that meets the eligibility criteria established by law. Entitlements constitute a binding obligation on the part of the Federal Government, and eligible recipients have legal recourse if the obligation is not fulfilled. Social Security and veterans' compensation and pensions are examples of entitlement programs.
  • 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
  • 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.
  • Ex officio: Literally, by virtue of one's office.
  • Fiscal year: The fiscal year is the accounting period for the government. For the federal government, this begins on October 1 and ends on September 30. The fiscal year is designated by the calendar year in which it ends; for example, fiscal year 2006 begins on October 1, 2005 and ends on September 30, 2006.
  • individual: shall include every infant member of the species homo sapiens who is born alive at any stage of development. See 1 USC 8
  • Joint committee: Committees including membership from both houses of teh legislature. Joint committees are usually established with narrow jurisdictions and normally lack authority to report legislation.
  • 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.
  • Layover: Informal term for a period of delay required by rule. For example, when a bill or other measure is reported from committee, it may be considered on the floor only after it "lies over" for one legislative day and after the written report has been available for two calendar days. Layover periods may be waived by unanimous consent.
  • 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
  • Obligation: An order placed, contract awarded, service received, or similar transaction during a given period that will require payments during the same or a future period.
  • Partnership: A voluntary contract between two or more persons to pool some or all of their assets into a business, with the agreement that there will be a proportional sharing of profits and losses.
  • Personal property: All property that is not real property.
  • President pro tempore: A constitutionally recognized officer of the Senate who presides over the chamber in the absence of the Vice President. The President Pro Tempore (or, "president for a time") is elected by the Senate and is, by custom, the Senator of the majority party with the longest record of continuous service.
  • Remainder: An interest in property that takes effect in the future at a specified time or after the occurrence of some event, such as the death of a life tenant.
  • 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.
  • State: means a State, the District of Columbia, the Commonwealth of Puerto Rico, or any other territory or possession of the United States. See 1 USC 7
  • Trial: A hearing that takes place when the defendant pleads "not guilty" and witnesses are required to come to court to give evidence.
  • User fees: Fees charged to users of goods or services provided by the government. In levying or authorizing these fees, the legislature determines whether the revenue should go into the treasury or should be available to the agency providing the goods or services.
  • writing: includes printing and typewriting and reproductions of visual symbols by photographing, multigraphing, mimeographing, manifolding, or otherwise. See 1 USC 1