PDF-[Type text]Contains Nonbinding RecommendationsDraft Guidance on Choles

This draft guidance when finalized will represent the current thinking of the Food and Drug Administration FDA or the Agency on this topic It does not establish any rights for any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 i. . It does not create or confer any rights for or on a ny person and does not operate to bind FDA or the public. You can use an alternat ive approach if the approach satisfies the requirements of the applicable statutes and regu lations. If you want to discuss an alternative approach, contact the Of fice of Generic Drugs. Active ingredient: Phentermine Hydrochloride Form/Route: Capsule/Oral Recommended studies: Phentermine Hydrochloride is a DESI ef . It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the Office of Generic Drugs. Active ingredient: Carisoprodol Form/Route: Tablet/Oral Recommended studie It does not create or confer any rights for or on any person and does not operate to bind FDA or the public You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations If you want to disc fdagovCosmeticGuidances You may submit written comments regarding th is guidance at any time Submit written comments on the guidance to the Division of Dockets Management H FA305 Food and Drug Administration 5630 Fishers La ne rm 1061 Rockville MD 20 This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA, or the Agency) on this topic. It does not establish any rights for any person and i This draft guidance, once finalized, will represent the Food and Drug Administration ’ s (FDA ’ s) urrent thinking on this topic. It does not create or confer any rights for or on any pers GUIDANCE FOR INDUSTRY
Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Nelfinavir Mesylate This draft guidance, once finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on a This d raft guidance , once finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic.It does not create or confer any rights for or on any person and does n Guidance for Industry and Food and Drug Administration Staff Document issued on June 21, 2016. This document will be in effect as of September 19, 2016.The draft of this document was issued on May 6, This draft guidance, once finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does no This draft guidance when finalized will represent the current thinking of the Food and Drug Administration FDA or the Agency on this topic Itdoes not establish any rights for any person and is not bi This draft guidance, when finalized, will represent the current thinking of the Food and Dr u g Administration (FDA, or the Agency) on this topic. It does not establish any rights for any person and Recommended Dec This d raft guidance current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind the FDA or the public. You can use an alt