A Sponsor’s View on Postmarketing Regulatory Commitments Involving Human Drug Products-Reference-Cited by-同舟云学术

A Sponsor’s View on Postmarketing Regulatory Commitments Involving Human Drug Products

Published:2021-07-12 Issue: Volume: Page:
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin Pharmacol Ther

Author:

McKinley Laura¹,Pressler Milton L¹,Hiatt Mary A.¹,Gregory William²

Affiliation:

1. Pfizer Global Product Development New York New York USA

2. Pfizer Worldwide Safety New York New York USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2335

Reference12 articles.

1. FDA postmarketing requirements and commitments: introduction. Accessed March 24 2021.

2. European Medicines Agency Human Regulatory: Post‐Authorisation. Accessed March 24 2021.

3. Development of Drug Therapies for Newborns and Children

4. European Medicines Agency reflection paper on the use of extrapolation in the development of medicines for paediatrics. (2018) . Accessed December 2 2020.

5. ICH Final Concept Paper on Pediatric Extrapolation. (2017) . Accessed December 2 2020.

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1. A Sponsor’s Perspective on the Contribution of Regulatory-Required Observational Post-Marketing Studies to Understanding Human Drug Product Benefit/Risk in Japan;Pharmaceutical Medicine;2024-03-31

2. US FDA Postmarketing Requirements and Commitments: A Systematic Assessment of Clinical Pharmacology Studies and Their Impact on US FDA Prescribing Information;The Journal of Clinical Pharmacology;2023-02-28