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Recommended Apr 2014, Revised Sept 2015, Revised Oct 2016, Oct 2018 This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA, or the Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the Office of Generic Drugs.

The Interrelationship between Arterial Calcification and Serum Estradiol Levels and Bone Mineral Content in the Aged