The proposed rule is part of FDA’s effort to “harmonize the requirements for prescription and nonprescription products and make them consistent with long-standing Agency policy.” Furthermore, the Agency stated that the rule would mandate applicable products to meet specific evidentiary requirements for approval.
Are you in the process of developing a prescription or OTC fixed-combination or co-packaged product that may be effected by this regulation? Do you already have one on the market? We can help ensure that you are compliant with all applicable regulation. To learn more about our services and how we can help you, contact us today.
FDA Reopens Comment Period on Proposed Labeling Regulations for “Conventional Foods” & Dietary Supplements
On March 3, 2014, FDA announced a proposed rule that would amend the regulations regarding the labeling of conventional foods and dietary supplements. In this announcement, the Agency sought feedback...