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China encourages pharmaceutical companies to timely pursue new GMP certification
- Sidley Austin LLP
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- China
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- January 15 2013
In 2010, China's State Food and Drug Administration ("SFDA") issued a new version of its Good Manufacturing Practice (the "GMP") regulations, which
FDA draft guidance on Dear Health Care Provider letters carries potentially significant products liability implications
- Sidley Austin LLP
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- USA
- -
- November 19 2010
The Food and Drug Administration (FDA) draft Guidance (Guidance) addressing the content and format of Dear Health Care Provider (DHCP) letterswhich are sometimes called "Dear Doctor" lettersis the first substantive guidance from FDA on this issue
Significant overhaul of EU medical devices regime planned
- Sidley Austin LLP
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- European Union
- -
- October 29 2012
On 26 September 2012, the European Commission published the proposals for two new Regulations intended to replace the EU directives that govern medical devices intended to be placed on the EU market
Major vaccine standards change in China
- Sidley Austin LLP
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- China
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- January 24 2011
The State Food and Drug Administration ("SFDA") recently issued the Notice for Further Strengthening the Supervision of Quality and Safety of Vaccines ("Vaccine Notice"
FDA proposes two groundbreaking food safety rules
- Sidley Austin LLP
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- USA
- -
- January 8 2013
On January 4, 2013, the U.S. Food and Drug Administration ("FDA" or the "Agency") proposed two major, long-awaited rulemakings required by the Food Safety
China proposes new ADR reporting rule
- Sidley Austin LLP
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- China
- -
- July 30 2009
On June 30, the Ministry of Health ("MOH") and the State Food and Drug Administration ("SFDA") of China issued a draft revision of the Rule on Adverse Drug Reaction Reporting and Monitoring (the "Reporting Rule"
Recent SFDA and MOH new developments
- Sidley Austin LLP
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- USA
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- January 21 2011
The State Food and Drug Administration ("SFDA, the Agency") issued an order in late December 2010 to require compulsory incorporation of a monitoring bar code issued by the agency in the direct packaging materials of compound pharmaceutical formulations containing ephedrine, codeine and diphenoxylate, in order to prevent abuse and misuse of such products
China's new SFDA priorities
- Sidley Austin LLP
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- China
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- February 1 2011
The General Commissioner of the State Food and Drug Administration ("SFDA") unveiled six key priorities of the agency in 2011 at the General Assembly of Food and Drug Administrations in China
China SFDA publishes new technical review guidelines for drugs
- Sidley Austin LLP
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- China
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- March 29 2011
On March 23, 2011, the Center for Drug Evaluation (CDE) of the PRC State Food and Drug Administration (SFDA), the equivalent of the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration, published new guidelines for its technical review of drug registration applications in China (the Guidelines), including applications for clinical studies (IND), applications for production and market approvals of new drugs (NDA), as well as applications for generic drugs (ANDA
New age of Singapore’s regulations of medical devices
- Sidley Austin LLP
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- Singapore
- -
- June 9 2011
In the past several years, Singapore has been in the process of revamping its regulatory regime for health products
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