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

The Tuning Project began in 000 as an initiative funded by the European Commission to develop common core learning outcomes/competences for degree programmes in Europe. It aimed to promote harmonisation in the Higher Education sector in support of the Bologna Declaration and subsequent developments. Beginning in 004, the Tuning (Medicine) Task Force has now generated and gained widespread consensus on a set of learning outcomes for primary medical degree qualifications in Europe. The work has been done under the auspices of the MEDINE Thematic Network for Medical Education in Europe, and was funded by the European Commission. The outcomes take. | 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Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration DRAFT GUIDANCE I his guidance ilncumcnl is heinp distributed for ciimmcnl purposes only.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be submitted within 90 days of publication in the FerfffMCi Register of the notice announcing the availability of the draft guidance.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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• outcomes competences
• Cytokinins and Their
• Possible Role
• Seed Size
• Determination
• Nutritional and Proteomic
• ostgraduate medical training
• Drought in Annual
• Crop Species
• Plant Heavy
• Metal Interaction
• Water Relations
• Enzyme Therapy
• Follow up
• Principles and Strategies
• Monitoring Individual
• Reproduction
• public health needs
• clearly inadequate
• government procurement