Orphan Drug Development—International Program and Study Design Issues-Reference-Cited by-同舟云学术

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Orphan Drug Development—International Program and Study Design Issues

Published:1998-01 Issue:1 Volume:32 Page:93-99
ISSN:0092-8615
Container-title:Drug Information Journal
language:en
Short-container-title:Drug Information J

Author:

Haffner Marlene E.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Drug Guides,Pharmacology (nursing)

Link

http://link.springer.com/content/pdf/10.1177/009286159803200113.pdf

Reference8 articles.

1. U.S. Federal Food, Drug, and Cosmetic Act (FFDCA). 21 USCA, § 201, et seq.

2. FFDCA SEC. 505(d); 21 USCA § 355(d) (Safety and effectiveness requirements).

3. P.L. 97–414, January 4, 1983 (The Orphan Drug Act).

4. FFDCA, SEC. 525; 21 USCA § 360aa (Recommendations for Investigations of drugs for rare diseases).

5. Section 1.28-1, Title 26, CFR (IRS Regulations on Rare disease research tax credit).

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1. REGULATION OF HUMAN PHARMACEUTICAL SAFETY: ROUTES TO HUMAN USE AND MARKET;Drug Safety Evaluation;2022-12-23

2. REGULATION OF HUMAN PHARMACEUTICAL SAFETY;Drug Safety Evaluation;2017-01-03

3. Ethical and Social Aspects on Rare Diseases;PHILOS SOC-FILOZOFIJ;2012

4. Regulation of Human Pharmaceutical Safety;Drug Safety Evaluation;2011-08-16

5. Policy alternatives for treatments for rare diseases;Canadian Medical Association Journal;2010-07-12

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