All > Healthcare > Medicine > Drug

• A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

  FDA - Cite This Source - This Definition
  ×

  Cite Definition for Reference Listed Drug (RLD)

  American Psychological Association (APA)

  Reference Listed Drug (RLD). (n.d.). [email protected] Glossary of Terms. Retrieved February 2, 2023, from website: http://www.expertglossary.com/definition/reference-listed-drug-rld.

  Chicago Manual of Style (CMS)

  Reference Listed Drug (RLD). www.fda.gov. [email protected] Glossary of Terms. FDA. http://www.expertglossary.com/definition/reference-listed-drug-rld (accessed: February 2, 2023).

  Modern Language Association (MLA)

  "Reference Listed Drug (RLD)." [email protected] Glossary of Terms. FDA. 2 February. 2023 http://www.expertglossary.com/definition/reference-listed-drug-rld.

• Browse Related Terms: Approval History, Discontinued Drug Product, FDA Action Date, label, Marketing Status, Reference Listed Drug (RLD), Route, Supplement, Supplement Number, Supplement Type, Tentative Approval

All > Healthcare > Medicine > Drug

• Slowing of respiration (breathing) that results in the reduced availability of oxygen to vital organs.

  National Institute on Drug Abuse - Cite This Source - This Definition
  ×

  Cite Definition for Respiratory Depression

  American Psychological Association (APA)

  Respiratory Depression. (n.d.). NIH Prescription Drug Abuse Glossary. Retrieved February 2, 2023, from website: http://www.expertglossary.com/definition/respiratory-depression.

  Chicago Manual of Style (CMS)

  Respiratory Depression. www.drugabuse.gov. NIH Prescription Drug Abuse Glossary. National Institute on Drug Abuse. http://www.expertglossary.com/definition/respiratory-depression (accessed: February 2, 2023).

  Modern Language Association (MLA)

  "Respiratory Depression." NIH Prescription Drug Abuse Glossary. National Institute on Drug Abuse. 2 February. 2023 http://www.expertglossary.com/definition/respiratory-depression.

• Browse Related Terms: barbiturate, Benzodiazepine, CNS Depressants, Narcolepsy, Polydrug Abuse, Prescription Drug Abuse, Psychotherapeutics, Respiratory Depression, Sedatives, Tranquilizers

All > Healthcare > Medicine > Drug

• A review is the basis of FDA's decision to approve an application. It is a comprehensive analysis of clinical trial data and other information prepared by FDA drug application reviewers. A review is divided into sections on medical analysis, chemistry, clinical pharmacology, biopharmaceutics, pharmacology, statistics, and microbiology.

  FDA - Cite This Source - This Definition
  ×

  Cite Definition for Review

  American Psychological Association (APA)

  Review. (n.d.). [email protected] Glossary of Terms. Retrieved February 2, 2023, from website: http://www.expertglossary.com/definition/review.

  Chicago Manual of Style (CMS)

  Review. www.fda.gov. [email protected] Glossary of Terms. FDA. http://www.expertglossary.com/definition/review (accessed: February 2, 2023).

  Modern Language Association (MLA)

  "Review." [email protected] Glossary of Terms. FDA. 2 February. 2023 http://www.expertglossary.com/definition/review.

• Browse Related Terms: Abbreviated New Drug Application (ANDA), Abbreviated New Drug Application (ANDA) Number, application, Application Number, Approval Letter, Biologic License Application (BLA), Company, FDA Application Number, New Drug Application (NDA), New Drug Application (NDA) Number, Product Number, Review, Review Classification

Also listed in:

• All > Law
• All > Law > E-Discovery

All > Healthcare > Medicine > Drug

• The NDA and BLA classification system provides a way of describing drug applications upon initial receipt and throughout the review process and prioritizing their review. (List of Review Classifications and their meanings)

  FDA - Cite This Source - This Definition
  ×

  Cite Definition for Review Classification

  American Psychological Association (APA)

  Review Classification. (n.d.). [email protected] Glossary of Terms. Retrieved February 2, 2023, from website: http://www.expertglossary.com/definition/review-classification.

  Chicago Manual of Style (CMS)

  Review Classification. www.fda.gov. [email protected] Glossary of Terms. FDA. http://www.expertglossary.com/definition/review-classification (accessed: February 2, 2023).

  Modern Language Association (MLA)

  "Review Classification." [email protected] Glossary of Terms. FDA. 2 February. 2023 http://www.expertglossary.com/definition/review-classification.

• Browse Related Terms: Abbreviated New Drug Application (ANDA), Abbreviated New Drug Application (ANDA) Number, application, Application Number, Approval Letter, Biologic License Application (BLA), Company, FDA Application Number, New Drug Application (NDA), New Drug Application (NDA) Number, Product Number, Review, Review Classification

All > Healthcare > Medicine > Drug

• A route of administration is a way of administering a drug to a site in a patient. A comprehensive list of specific routes of administration appears in the CDER Data Standards Manual.

  FDA - Cite This Source - This Definition
  ×

  Cite Definition for Route

  American Psychological Association (APA)

  Route. (n.d.). [email protected] Glossary of Terms. Retrieved February 2, 2023, from website: http://www.expertglossary.com/definition/route.

  Chicago Manual of Style (CMS)

  Route. www.fda.gov. [email protected] Glossary of Terms. FDA. http://www.expertglossary.com/definition/route (accessed: February 2, 2023).

  Modern Language Association (MLA)

  "Route." [email protected] Glossary of Terms. FDA. 2 February. 2023 http://www.expertglossary.com/definition/route.

• Browse Related Terms: Approval History, Discontinued Drug Product, FDA Action Date, label, Marketing Status, Reference Listed Drug (RLD), Route, Supplement, Supplement Number, Supplement Type, Tentative Approval

Also listed in:

• All > Technology > GIS
• All > Technology > Telecommunications