date:Nov 23, 2015
final formulation testing that it anticipates adopting in the future.
FDA is issuing this guidance in partial implementation of the SIA (Pub. L. 113-195), enacted November 26, 2014, which amended the Federal Food, Drug, and Cosmetic Act (the FD Draft Guidance for Industry; Availability.” 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.
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