Enum: ApprovalStatusEnum

Permissible Values

Value	Meaning	Description
discovery_and_development_phase	None	Discovery & Development Phase. Discovery involves researchers finding new possibilities for medication through testing molecular compounds, noting unexpected effects from existing treatments, or the creation of new technology that allows novel ways of targeting medical products to sites in the body. Drug development occurs after researchers identify potential compounds for experiments.
preclinical_research_phase	None	Preclinical Research Phase. Once researchers have examined the possibilities a new drug may contain, they must do preliminary research to determine its potential for harm (toxicity). This is categorized as preclinical research and can be one of two types: in vitro or in vivo.
fda_clinical_research_phase	None	Clinical Research Phase. Clinical research involves trials of the drug on people, and it is one of the most involved stages in the drug development and approval process. Clinical trials must answer specific questions and follow a protocol determined by the drug researcher or manufacturer.
fda_review_phase_4	None	FDA Review
fda_post_market_safety_review	None	FDA Post-Market Safety Monitoring. The last phase of drug approval is an ongoing one while the drug is on the marketplace. If a developer wants to change anything about the drug formulation or approve it for a new use, they must apply with the FDA. The FDA also frequently reviews the drug’s advertising and its manufacturing facility to make sure everything involved in its creation and marketing is in compliance with regulations.
fda_clinical_research_phase_1	None	In the FDA Clinical Research Phase, the Clinical Research Phase 1 involves 20 – 100 study participants and lasts several months. This phase is used to determine the safety and dosage of the drug, and about 70% of these drugs move on to the next clinical research phase.
fda_clinical_research_phase_2	None	In the FDA Clinical Research Phase, the Clinical Research Phase 2 involves up to several hundred people, who must have the disease or condition the drug supposes to treat. This phase can last from a few months to two years, and its purpose is to monitor the efficacy of the drug, as well as note side effects that may occur.
fda_clinical_research_phase_3	None	In the FDA Clinical Research Phase, the Clinical Research Phase 3 involves 300 – 3000 volunteers and can last up to four years. It is used to continue monitoring the efficacy of the drug, as well as exploring any longer-term adverse reactions.
fda_clinical_research_phase_4	None	In the FDA Clinical Research Phase, the Clinical Research Phase 4 involves several thousands of volunteers who have the disease or condition and continues to monitor safety and efficacy. If a drug passes this phase, it goes on to FDA review.
fda_fast_track	None	Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions. For more information https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
fda_breakthrough_therapy	None	Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s). For more information https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy
fda_accelerated_approval	None	When studying a new drug, it can sometimes take many years to learn whether a drug actually provides a real effect on how a patient survives, feels, or functions. A positive therapeutic effect that is clinically meaningful in the context of a given disease is known as “clinical benefit”. Mindful of the fact that it may take an extended period of time to measure a drug’s intended clinical benefit, in 1992 FDA instituted the Accelerated Approval regulations. These regulations allowed drugs for serious conditions that filled an unmet medical need to be approved based on a surrogate endpoint. Using a surrogate endpoint enabled the FDA to approve these drugs faster. For more information https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval
fda_priority_review	None	Prior to approval, each drug marketed in the United States must go through a detailed FDA review process. In 1992, under the Prescription Drug User Act (PDUFA), FDA agreed to specific goals for improving the drug review time and created a two-tiered system of review times – Standard Review and Priority Review. A Priority Review designation means FDA’s goal is to take action on an application within 6 months (compared to 10 months under standard review). For more information https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review
regular_fda_approval	None	Regular FDA Approval. The last phase of drug approval is an ongoing one while the drug is on the marketplace. If a developer wants to change anything about the drug formulation or approve it for a new use, they must apply with the FDA. The FDA also frequently reviews the drug’s advertising and its manufacturing facility to make sure everything involved in its creation and marketing is in compliance with regulations.
post_approval_withdrawal	None	None

Slots constrained by this enum

Name
highest_FDA_approval_status
drug_regulatory_status_world_wide

LinkML Source

name: ApprovalStatusEnum
description: ''
from_schema: https://w3id.org/biolink/biolink-model
permissible_values:
  discovery_and_development_phase:
    text: discovery_and_development_phase
    description: Discovery & Development Phase. Discovery involves researchers finding
      new possibilities for medication through testing molecular compounds, noting
      unexpected effects from existing treatments, or the creation of new technology
      that allows novel ways of targeting medical products to sites in the body. Drug
      development occurs after researchers identify potential compounds for experiments.
  preclinical_research_phase:
    text: preclinical_research_phase
    description: 'Preclinical Research Phase.  Once researchers have examined the
      possibilities a new drug may contain, they must do preliminary research to determine
      its potential for harm (toxicity). This is categorized as preclinical research
      and can be one of two types: in vitro or in vivo.'
  fda_clinical_research_phase:
    text: fda_clinical_research_phase
    description: Clinical Research Phase. Clinical research involves trials of the
      drug on people, and it is one of the most involved stages in the drug development
      and approval process. Clinical trials must answer specific questions and follow
      a protocol determined by the drug researcher or manufacturer.
  fda_review_phase_4:
    text: fda_review_phase_4
    description: FDA Review
  fda_post_market_safety_review:
    text: fda_post_market_safety_review
    description: FDA Post-Market Safety Monitoring.  The last phase of drug approval
      is an ongoing one while the drug is on the marketplace. If a developer wants
      to change anything about the drug formulation or approve it for a new use, they
      must apply with the FDA. The FDA also frequently reviews the drug’s advertising
      and its manufacturing facility to make sure everything involved in its creation
      and marketing is in compliance with regulations.
  fda_clinical_research_phase_1:
    text: fda_clinical_research_phase_1
    description: In the FDA Clinical Research Phase, the Clinical Research Phase 1
      involves 20 – 100 study participants and lasts several months. This phase is
      used to determine the safety and dosage of the drug, and about 70% of these
      drugs move on to the next clinical research phase.
  fda_clinical_research_phase_2:
    text: fda_clinical_research_phase_2
    description: In the FDA Clinical Research Phase, the Clinical Research Phase 2
      involves up to several hundred people, who must have the disease or condition
      the drug supposes to treat. This phase can last from a few months to two years,
      and its purpose is to monitor the efficacy of the drug, as well as note side
      effects that may occur.
  fda_clinical_research_phase_3:
    text: fda_clinical_research_phase_3
    description: In the FDA Clinical Research Phase, the Clinical Research Phase 3
      involves 300 – 3000 volunteers and can last up to four years. It is used to
      continue monitoring the efficacy of the drug, as well as exploring any longer-term
      adverse reactions.
  fda_clinical_research_phase_4:
    text: fda_clinical_research_phase_4
    description: In the FDA Clinical Research Phase, the Clinical Research Phase 4
      involves several thousands of volunteers who have the disease or condition and
      continues to monitor safety and efficacy. If a drug passes this phase, it goes
      on to FDA review.
  fda_fast_track:
    text: fda_fast_track
    description: Fast track is a process designed to facilitate the development, and
      expedite the review of drugs to treat serious conditions and fill an unmet medical
      need. The purpose is to get important new drugs to the patient earlier. Fast
      Track addresses a broad range of serious conditions. For more information https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
  fda_breakthrough_therapy:
    text: fda_breakthrough_therapy
    description: Breakthrough Therapy designation is a process designed to expedite
      the development and review of drugs that are intended to treat a serious condition
      and preliminary clinical evidence indicates that the drug may demonstrate substantial
      improvement over available therapy on a clinically significant endpoint(s).
      For more information https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy
  fda_accelerated_approval:
    text: fda_accelerated_approval
    description: When studying a new drug, it can sometimes take many years to learn
      whether a drug actually provides a real effect on how a patient survives, feels,
      or functions. A positive therapeutic effect that is clinically meaningful in
      the context of a given disease is known as “clinical benefit”. Mindful of the
      fact that it may take an extended period of time to measure a drug’s intended
      clinical benefit, in 1992 FDA instituted the Accelerated Approval regulations.
      These regulations allowed drugs for serious conditions that filled an unmet
      medical need to be approved based on a surrogate endpoint. Using a surrogate
      endpoint enabled the FDA to approve these drugs faster. For more information
      https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval
  fda_priority_review:
    text: fda_priority_review
    description: Prior to approval, each drug marketed in the United States must go
      through a detailed FDA review process. In 1992, under the Prescription Drug
      User Act (PDUFA), FDA agreed to specific goals for improving the drug review
      time and created a two-tiered system of review times – Standard Review and Priority
      Review. A Priority Review designation means FDA’s goal is to take action on
      an application within 6 months (compared to 10 months under standard review).
      For more information https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review
  regular_fda_approval:
    text: regular_fda_approval
    description: Regular FDA Approval.  The last phase of drug approval is an ongoing
      one while the drug is on the marketplace. If a developer wants to change anything
      about the drug formulation or approve it for a new use, they must apply with
      the FDA. The FDA also frequently reviews the drug’s advertising and its manufacturing
      facility to make sure everything involved in its creation and marketing is in
      compliance with regulations.
  post_approval_withdrawal:
    text: post_approval_withdrawal