Navigating Through a Complex and Inconsistent Regulatory Framework: Section 503B of the Federal Food Drug and Cosmetic Act Outsourcing Facilities Engaged in Clinical Investigation-Reference-Cited by-同舟云学术

Navigating Through a Complex and Inconsistent Regulatory Framework: Section 503B of the Federal Food Drug and Cosmetic Act Outsourcing Facilities Engaged in Clinical Investigation

Published:2016-05 Issue:3 Volume:50 Page:270-278
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Palumbo Francis B.,Rosebush Lee H.,Zeta Lowell M.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Link

http://link.springer.com/content/pdf/10.1177/2168479015618695.pdf

Reference67 articles.

1. Pharmaceutical Research and Manufacturers of America (PhRMA). 2013 Biopharmaceutical research industry profile, pharmaceutical research and manufacturers of America: introduction. http://www.phrma.org/sites/default/files/pdf/PhRMA%20Profile%202013.pdf. Published July 2013. Accessed January 15, 2016.

2. US Pharmacopeia. Chapter 795, Pharmaceutical Compounding—Nonsterile Preparations (2014).

3. Allen LV Jr. The Art, Science and Technology of Pharmaceutical Compounding. 4th ed., American Pharmacists Association 2012

4. Western States Med Ctr v Shalala, 238 F3d 1090 (9th Cir 2001).

5. Kessler DA, MD, Commissioner of Food and Drugs, Department of Health and Human Services. Speech presented at: Subcommittee on Health and Environment, Committee on Commerce, House of Representatives; May 1, 1996.

Cited by 2 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Galenic formulations as solutions to dosage form problems;Macedonian Pharmaceutical Bulletin;2022-12-31

2. Pharmaceutical Compounding: a History, Regulatory Overview, and Systematic Review of Compounding Errors;Journal of Medical Toxicology;2020-11-02