💊FDA Draft Guidance on Aluminum Content in Parenteral Nutrition Products
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations." This draft guidance is intended to clarify the key factors in calculating the aluminum content to ensure that the total aluminum exposure in parenteral nutrition (PN) does not exceed an acceptable threshold. It also provides FDA's recommendations regarding the aluminum concentration limits for small volume parenterals (SVPs) packaged as single doses or SVPs packaged in pharmacy bulk packages (PBPs). Additionally, this draft guidance is intended to assist sponsors and applicants in determining the appropriate placement of information on aluminum toxicity in SVP and large volume parenteral (LVP) Prescribing Information and container and carton labeling. This draft guidance revises and replaces the draft guidance for industry of the same name published on December 7, 2022.
Learn More🥛FDA Extends Yogurt Market Testing Permit for Chobani, LLC
The Food and Drug Administration (FDA or we) is announcing the amendment to the temporary permit issued to Chobani, LLC, (Chobani) to market test yogurt deviating from the yogurt standard of identity and lower fat yogurt products deviating from the general definition and standard of identity in 21 CFR 130.10 by using ultrafiltered nonfat milk as a basic dairy ingredient. We are also announcing an extension to this permit, which allows Chobani to continue to evaluate commercial viability of these products and to collect data on consumer acceptance of these products in support of a petition to amend the standard of identity for yogurt. We also invite other interested parties to participate in the market test.
Learn More📋FDA Reopens Comment Period for Good Clinical Practice Guidance
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the draft guidance for industry entitled "E6(R3) Good Clinical Practice: Annex 2," announced in the Federal Register of December 30, 2024. The Agency is taking this action to allow interested persons additional time to submit comments.
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