Changzhou, China
Changzhou, China

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Bolger G.R.,Z Biomedical Inc. | Tu Y.-R.,Changzhou Siyao Pharm Co. | Sun P.-H.,Changzhou Siyao Pharm Co. | Xie G.-W.,Changzhou Siyao Pharm Co. | And 2 more authors.
Chinese Journal of New Drugs | Year: 2014

Timely and effective sharing of information about drug safety with the public, medical community and health care professionals is one of U.S. FDA's top priorities. To prevent events like the Vioxx disaster from happening again and ensure FDA-approved drugs can be used safely and effectively for achieving the optimum effect and improving the health of patients, the U.S. FDA has drafted, established and amended a series of related regulations, guidances and initiatives in the past 10 years. Based on these regulations and guidances, U.S. FDA has established and enhanced an internet-based and integrated drug safety information communication/sharing platform which includes the Drug Safety Communications, Drug Safety Podcasts, MedWatch toll-free phone number and website, FDA's FaceBook, Twitter and YouTube websites, Drug Safety Labeling Changes, Drug Recalls, and Drug Quality Reporting System. This article provides a concise overview of the current U.S. FDA's drug safety information communication/sharing platform and quality reporting system.

Eshelman R.A.,Z Biomedical Inc. | Tu Y.-R.,Changzhou Siyao Pharm Co. | Yan Y.-M.,Changzhou Siyao Pharm Co. | Guo X.,Changzhou Siyao Pharm Co. | Zhang H.,Z Biomedical Inc.
Chinese Journal of New Drugs | Year: 2013

Most of the over-the-counter (OTC) drug products on the U.S. market in 1972 had not been approved by the Food and Drug Administration (FDA) through the new drug application process of the Federal Food, Drug, and Cosmetic Act (FD&C). In 1972 the FDA began a comprehensive review of these OTC drugs to establish conditions whereby the ingredients in the products are generally recognized as safe and effective for their intended uses. The final regulations under this review set forth the specific conditions whereby an OTC drug could be legally marketed without obtaining an approved new drug application. OTC drugs that conform to these final regulations would also need to comply with all other applicable laws and regulations, including general labeling requirements, current good manufacturing practices, and drug registration and listing.

Changzhou Siyao Pharm Co. and Utopharm Shanghai Co. | Date: 2012-07-12

A method as well as new intermediates for preparing Ulipristal acetate (a compound I) and a method for preparing the new intermediates are provided. The intermediate in a constitutional formula IV is conductive to reacting with methyl lithium or methyl Grignard reagent, a protective group is easy to be removed after a reaction, side reactions are few, a mid-term treatment is simple, the reagents used are cheap, costs are low and a yield is high, if a compound in a constitutional formula V is obtained by the reaction of a compound in a constitutional formula III and the intermediate in the constitutional formula IV, the yield of a two-step reaction is 75%, a purity is above 98%. wherein R is defined in the specification.

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