tailieunhanh - Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration

The key driver in this change has been India's demographic makeup, as the nation's booming economy rapidly adds to the near–critical mass of newly affluent consumers. The average salary of Indians has grown 14% (those of IT professionals have grown by 18%), which is probably the highest wage growth in Asia. 3 There are now about million Indian households that spend an average of $9,000 (Rs. 4,50,000) a year on luxury goods, according to The Knowledge Company, a management-consulting firm in New Delhi. Mr. Thakran of LVMH says "With multi-income families and increasing international exposure through travel and the Internet,. | Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration DRAFT GUIDANCE I his guidance ilncumcnl is heinp distributed for ciimmcnl purposes only. Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the FerfffMCi Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management I FA-305 Food and Dfrujj AdtHÌTÚstraiiun. 5630 Fish lies Lane rm. 1061 Rockville MO 20B52. AH cottimeurtj should be identified With the docket number listed In die notice of availability that publishes in the Federal Register For questions regarding this draft document contact CSFR Sheryl LanJ-Whiicfbrd at 301-8270379. CD ER Daniel Nguyen at 301-827-8971 CDRH Ted Steven 11301-594-1184 or CFS AN Wayne Amchin at 301 -827-6739. L s. Department of Health and Human Services Food and Drug Administration December KJ66 A 4 j ũụỷp ư i- I Guidance for Industry Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration Atk iiiotiiìỉ ỉũpieí are avaitabie from Office iff Cnmmunicatiỉm. Training íi ỉỉỉ Assistance ỈỈFM-4Qị Center far Ỉhíĩỉfỉ ii ỉ Evaluation tittíỉ Research Food ưttif Drug Administration 40 ỌùckviỉÍỂ PAe. Suite 200N Rockville. MD20HĨĨ- 448 Phone 800-8J5 709 or ỉo -827- 800 Internet hltp. M 1411 . guu t . Department o r tl L J till uctl ilurtisn Services F d And Drug AdmiiũĩtrAlien Center for BiữlogỂcỉ Evnluatijon and Research CBER Center for Drug KvaluAlton and Research ICD R I Center for I Jfvices and Hadioỉogícal Health CDffitH Center for Food Safety and Applied Nutrition CFSAN December 20ŨẾ 2 Table of Contents L Why Are We Issuing This Guidance .1 II. Whiil Is Complementary and Alternative Med cine CAM X 2 A. what Are Biologically Based Practices 1 . . 3 B- What Energy Medicine 1 . 4

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