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FDA issues warning letter to Lancôme for anti-aging claims

USA - September 14 2012 On September 7, 2012, the compliance office within the Center for Food Safety and Applied Nutrition (CFSAN) at FDA issued a Warning Letter to Lancôme USA, a subsidiary of L’Oréal, regarding several anti-aging skin care products being marketed as cosmetics.

Scott Bass, Raymond A. Bonner, Coleen Klasmeier

China encourages pharmaceutical companies to timely pursue new GMP certification

China - 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…

Scott Bass, Zhengyu Tang, Yuet Ming Tham, Chen Yang

FDA releases draft guidance concerning clinical trials

USA - December 6 2012 On November 20, the Food and Drug Administration (FDA) took another step toward modernizing clinical trial oversight by issuing two draft guidance documents related to the conduct of clinical trials.

Scott Bass, Raymond A. Bonner, Coleen Klasmeier

Sidley Austin LLP global pricing newsletter - volume three 2014

Brazil, Canada, China, European Union, France, Germany, India, United Kingdom, USA - April 15 2014 On October 21, 2013, Brazil’s National Agency of Supplemental Health enacted Normative Resolution 388, which mandated that all private healthcare…

Maarten Meulenbelt, William A. Sarraille, Trevor L. Wear, Chen Yang

China promulgates a PSUR guidance for approved drugs

China - September 25 2012 On September 13, 2012, the State Food and Drug Administration (“SFDA”) published a Technical Guidance for the Periodic Safety Update Report for Marketed Drugs (the “PSUR Guidance”).

Scott Bass, Zhengyu Tang, Yuet Ming Tham, Chen Yang