Clinical pharmacology information in regulatory submissions and labeling: A comparative analysis of orphan and non‐orphan drugs approved by the FDA-Reference-Cited by-同舟云学术

Clinical pharmacology information in regulatory submissions and labeling: A comparative analysis of orphan and non‐orphan drugs approved by the FDA

Published:2022-09-27 Issue:11 Volume:15 Page:2583-2596
ISSN:1752-8054
Container-title:Clinical and Translational Science
language:en
Short-container-title:Clinical Translational Sci

Author:

Hsieh Julie¹,Sahre Martina¹,Yang Xinning¹,Madabushi Rajanikanth¹,Ramamoorthy Anuradha¹

Affiliation:

1. Office of Clinical Pharmacology, Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Publisher

Wiley

Subject

General Pharmacology, Toxicology and Pharmaceutics,General Biochemistry, Genetics and Molecular Biology,General Medicine,General Neuroscience

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/cts.13362

Reference39 articles.

1. Introduction to Clinical Pharmacology

2. US Food and Drug Administration.Manual of policies and procedures. Good review practices: clinical pharmacology reivew of New Molecular Entity (NME) New Drug Applications (NDAs) and original biologics license applications. Center for Drug Evaluation and Research Office of Clincial Pharmacology. MAPP 4000.4 Rev. 1.https://www.fda.gov/media/71709/download. Accessed August 20 2021.

3. US Food and Drug Administration. Guidance for Industry.Rare diseases: common issues in drug development. Draft Guidance. Published2019.https://www.fda.gov/media/119757/download. Accessed March 5 2021.

4. National Institute of Health.FAQs about rare diseases.https://rarediseases.info.nih.gov/diseases/pages/31/faqs‐about‐rare‐diseases. Accessed September 17 2021.

5. PhRMA.Meeting the need: rare diseases and the orphan drug act.https://www.phrma.org/‐/media/Project/PhRMA/PhRMA‐Org/PhRMA‐Org/PDF/P‐R/PhRMA‐Orphan‐Chart‐Pack_Final_10112019.pdf. Accessed October 12 2021.

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