Issue link: https://www.e-digitaleditions.com/i/723777
industry news FDA addresses elemental impurities SILVER SPRINGS, MD—The FDA issued a draft "Guidance for Industry: Elemental Impurities in Drug Pro- ducts." It states that US pharmaceutical manufacturers should follow Inter- national Council for Harmon- isation (ICH) guidance for industry "Q3D Elemental 18 Impurities" (ICH Q3D) to establish procedures for iden- tifying and controlling elemental impu- rities in drug products. Topics include how sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for noncompen- dial drug products should control ele- mental impurities; how manufacturers of compendial drug products not mar- keted under an approved NDA or ANDA can comply with USP general chapters <232> and <233>; how hold- ers of NDAs and ANDAs should report changes in chemistry, manufac- turing, and controls specifications to FDA; and how manufacturers of non- compendial drug products that are marketed under an approved NDA or ANDA should control for elemental impurities. The draft Guidance encour- ages early adoption of ICH Q3D and USP <232> and <233>. ODS funds research on dietary supplements BETHESDA, MD—The Office of Dietary Supplements (ODS) will fund research on the impact of dietary sup- plements and/or their ingredients on health maintenance and disease preven- tion. ODS has committed $3 million to fund 30 research awards. Primary con- sideration will be given to research of dietary supplements where research is lacking, needs clarification, targets spe- cial population groups where additional science on dietary supplements is needed, or focuses on the use of dietary supplements to improve or maintain health and reduce the risk of chronic disease. Applications are due October 15, 2016; January 15, 2017; and April 15, 2017. 7+20$6(1*,1((5,1*,1&:HVW&HQWUDO5G +RIIPDQ(VWDWHV,/7(/ :::7+20$6(1*&20 7+20$67$%/(7 35(66722/,1* 10 September 2016 Tablets & Capsules