Status and thoughts of Chinese patent medicines seeking approval in the US market

Author:

Lei Xiang,Chen Jing,Liu Chun-Xiang,Lin Jia,Lou Jing,Shang Hong-cai

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Complementary and alternative medicine,General Medicine

Reference26 articles.

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2. Department of Health and Human Services, Food and Drug Administration, US. Guidance for industry botanical drug products (EB/OL). http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070491.pdf .

3. Zhou H. The first American herbal medicine Veregen™’s introduction and enlightenment of Chinese medicine research and development. Tradit Chin Drug Res Clin Pharmacol (Chin) 2008;19:326–328.

4. Zhang ZJ, Chen YF, Ye ZL, Zhang XN, Dong HO. Information and enlightenment on the first oral botanical drug Fulyzaq approved by FDA. Drugs Clin (Chin) 2013;28:421–423.

5. ClinicalTrials.gov. Phase II multi-center study of T89 to treat chronic stable angina (T89 Phase 2). http://clinicaltrials.gov/ct2/show/NCT00797953?term=Dantonic&rank=5 .

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