Search Results for keywords:"Biological Products"

The Food and Drug Administration (FDA) has released a draft guidance for companies developing drugs and biological products aimed at preventing and treating chemotherapy-induced peripheral neuropathy (CIPN) in cancer patients. CIPN is a painful condition that can disrupt chemotherapy, affecting patients' survival by leading to treatment interruptions or dose reductions. The guidance offers recommendations for clinical trials, including the selection of trial participants and appropriate study endpoints. The public is encouraged to provide feedback on the draft by March 18, 2025, to help shape the final version.

The Food and Drug Administration (FDA) has issued five Emergency Use Authorizations (EUAs) for drugs and biological products during the COVID-19 pandemic. These authorizations, allowed under the Federal Food, Drug, and Cosmetic Act, aim to help address public health emergencies by making medical products available when there are no adequate alternatives. The products authorized include those requested by Baxter Healthcare, the U.S. Department of Health and Human Services, Eli Lilly and Company, and Regeneron Pharmaceuticals. The FDA ensures that these authorizations are based on scientific evidence indicating that the benefits of using these products outweigh the risks.

The Food and Drug Administration (FDA) has released draft guidance for the industry on using Artificial Intelligence (AI) to aid in regulatory decisions for drugs and biological products. This guidance explains how AI can be used to produce credible information or data regarding the safety, effectiveness, or quality of these products. It emphasizes a risk-based assessment framework for AI models and encourages early consultation with the FDA to ensure compliance and credibility. The guidance and its proposed recommendations are open for public comment until April 7, 2025, allowing stakeholders to contribute their views on the outlined framework and engagement options with the FDA.

The FDA has released a draft guidance titled "Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction" for public comment. This draft provides recommendations for developing drugs aimed at long-term weight loss and maintenance for individuals with obesity or overweight. It updates a previous guidance issued in 2007 and covers aspects like trial design, participant selection, and safety evaluations. The public can submit comments on the draft until April 8, 2025, to help shape the final version.