Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry | FDA

Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry | FDA

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August 12, 2020 - Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry - The purpose of this guidance is to help sponsors of investigational new drug applications (INDs) and applicants of biologic license applications (BLAs) determine the need for drug-drug interaction (DDI) studies for a therapeutic protein (TP) by providing a systematic, risk-based approach. August 12, 2020 - Male Breast Cancer: Developing Drugs for Treatment: Guidance for Industry - This guidance provides recommendations to sponsors regarding the development and labeling of cancer drugs, including biological products, regulated by the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) for the treatment of male patients with breast cancer. August 12, 2020 - Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods - The FDA issued a final rule to establish compliance requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, and that bear the “gluten-free” claim. The rule pertains to foods such as soy sauce, yogurt, sauerkraut, pickles, cheese and green olives. Distilled foods, such as distilled vinegars, are also included in the final rule.