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FDA Issues Two Guidance Documents on Food Allergen Labeling Requirements

The FDA Law Blog

Food and Drug Administration (FDA) issued two guidance documents, one draft and one final, on food allergen labeling requirements. 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g., 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g.,

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Hashimoto’s and Graves’ Remission after Helicobacter Pylori Eradication

The Thyroid Pharmacist

Source: Bertalot et al, 2004). Source: Bertalot et al, 2004). MegaGuard and PyloGuard provide doses on the package. Berberine containing quadruple therapy for initial Helicobacter pylori eradication: An open-label randomized phase IV trial. The five patients with Hashimoto’s and untreated H. 39,64-67). 2017;96(32):e7697.

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Environmental Sustainability in Biopharmaceutical Facility Design

ISPE

4 The biopharmaceutical industry is taking steps to increase its environmental sustainability, 5 which begins with identifying and testing alternatives to existing procurement, materials, logistics, equipment, services, manufacturing processes, packaging, and facility design 6 (see Table 1). 7 An integrative (vs. 7 An integrative (vs.

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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). Finally, the DP is packaged in a suitable container to ensure continued quality. This is followed by DP manufacturing, where the DS is formulated with excipients. Burke, S.,