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State Food and Drug Administration (China)

Novartis Receives Chinese OK for Eye Drug Lucentis

Jan 18 | News

Novartis said today that it received Chinese regulatory approval for its eye drug Lucentis, and it is launching the diabetes treatment Galvus in China.  

WuXi PharmaTech Awarded GLP Certificate from SFDA for Suzhou Toxicology Facility

Nov 8 2010 | News

WuXi PharmaTech, a pharmaceutical, biotechnology and medical device research and development outsourcing company with operations in China and the United States, today announced that it had been awarded a Certificate of Good Laboratory Practice (GLP) compliance from the State Food and Drug Administration (SFDA), China's regulatory authority for pharmaceuticals, for its toxicology facility in Suzhou.

Simcere Pharmaceutical Group Receives SFDA Approval to Manufacture and Market Palonosetron in China

Aug 12 2010 | News

Simcere Dongyuan Pharmaceutical Co., Ltd. has recently received SFDA new drug certification and registration approval to manufacture and market Palonosetron material and injections in China.

NeoStem's Suzhou Erye Pharmaceutical Subsidiary Passes Government Inspection for Two Manufacturing Lines at its New Facility

Jun 15 2010 | News

NeoStem, Inc., an international biopharmaceutical company with operations in the U.S. and China, announced that its Suzhou Erye pharmaceutical subsidiary ("Erye") passed the government inspection by the State Food and Drug Administration ("SFDA") in China to manufacture penicillin powder for injection and cephalosporin powder for injection at its new manufacturing facility which provides 50% greater manufacturing capacity than its existing plant.

Chinese Drug Regulation Official Fired Amid Probe

Jun 14 2010 | News

BEIJING (AP) — The deputy head of China's food and drug regulator is being investigated and has been dismissed from his post, a state news agency said Sunday, citing an anti-corruption agency.


Sinovac Selected by Beijing CDC to Supply Hepatitis A Vaccine Healive(R)

Jun 1 2010 | News

Sinovac Biotech Ltd., a China-based vaccine manufacturer, announced today that it has received the confirmation from the China International Tendering Company that Sinovac was selected by the Beijing Centers for Diseases Control and Prevention (Beijing CDC) to supply the Company's hepatitis A vaccine, Healive, to the Beijing Expanded Program of Immunization (EPI).  

Sinovac Submits Clinical Trial Application for Mumps Vaccine to SFDA

May 5 2010 | News

Sinovac Biotech Ltd., a China-based vaccine manufacturer, announced today that its 30%-owned joint venture, Sinovac Dalian, has submitted an application to China's State Food and Drug Administration (SFDA) to commence human clinical trials for its mumps vaccine.

MicuRx Pharmaceuticals Files Investigational New Drug Application for MRX-I

Mar 15 2010 | News

MicuRx Pharmaceuticals, Inc., a privately-held biopharmaceutical company developing next-generation antibiotics, today announced that it has filed an Investigational New Drug (IND) application with the State Food and Drug Administration (SFDA) in China for MRX-I

Blogs

When Is Software The Answer To Regulatory Concerns About Your Investigations?

When Is Software The Answer To Regulatory Concerns About Your Investigations?

Jan 30 | John Ager, Technical Consultant, Life Science, Kepner-Tregoe, Inc

Document management software enables investigators to present the information used to reach conclusions clearly and concisely and it helps reviewers to track and approve investigations.

The Benefits of Professional Project Management

The Benefits of Professional Project Management

Jan 13 | Thorsten Vammen, Director at GEA Liquid Processing in Skanderborg, Denmark

Some companies feel that they can project manage new processing facilities themselves, bringing in sub-contracted help only when it’s needed. Self-managing is possible, but there may be a better way.

Multimedia

Battle over Birth Control

Battle over Birth Control

Feb 9 | Video

CNN’s The Situation Room discusses the current dispute over health care coverage for contraception. Will there be a contraception compromise?

Government Seeking $1T Campaign Against Alzheimer's

Government Seeking $1T Campaign Against Alzheimer's

Jan 18 | Video

Government advisors tried to set priorities for a national campaign to treat and manage Alzheimer's disease, which is projected to cost more than a trillion dollars in care by 2050. But as Dr. Jon LaPook reports, the plan does not include any funding.

ADHD Drugs in Short Supply

ADHD Drugs in Short Supply

Jan 11 | Video

Parents of children with attention deficit disorders are forced to travel from pharmacy to pharmacy in search of prescription medicines with no guarantees they will be available.

Study: Link Between Statins And Diabetes

Study: Link Between Statins And Diabetes

Jan 10 | Video

A recent study reveals that women who take statins may have a greate chance of developing diabetes.

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