Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Monday, November 25, 2019
Statement from Acting FDA Commissioner Adm. Brett P. Giroir, M.D., on efforts to help make development of biosimilar and interchangeable insulin products more efficient
Access to affordable insulin can be a matter of life and death for Americans with diabetes. If not appropriately treated, diabetes can lead to serious and life-threatening complications, including heart disease, organ failure and blindness. And consistent, lifelong access to insulin is imperative to patient survival and quality of life. However, we are aware that the high cost of insulin raises serious concerns about the ability of many patients to access insulin products. This is an issue the FDA takes very seriously; therefore, today we are announcing new draft guidance that is intended to help facilitate the development of, and improve patient access to, life-saving insulin products.
The FDA is committed to continuing our efforts to help increase market competition among insulin products, which may potentially lower costs for patients and payors and increase access and product choice. This includes facilitating the development of safe and effective insulin products for the treatment of patients with Type 1 and Type 2 diabetes, including products that are biosimilar to...