Designating an Orphan Product: Drugs and Biological Products | FDA
The Orphan Drug Act provides for granting special status to a drug or biological product| U.S. Food and Drug Administration
The Orphan Drug Act provides for granting special status to a drug or biological product| U.S. Food and Drug Administration
The Centers for Medicare & Medicaid Services (CMS) recently announced the drugs selected for the second round of negotiation for the Medicare Drug Price Negotiation Program, which was established by the Inflation Reduction Act. These FAQs address several questions related to Medicare’s drug price negotiation program and CMS's implementation of the program, with a focus on the details that apply for 2027, the second year that negotiated prices will be available under the program.| KFF
In August 2022, President Biden signed the Inflation Reduction Act of 2022 (P.L. 117-169) into law. The law makes improvements to Medicare by expanding benefits, lowering drug costs, and improving the sustainability of the Medicare program for generations to come. The law provides meaningful financial relief for millions of people with Medicare by improving access to affordable treatments and strengthening Medicare, both now and in the long run.| www.cms.gov
The Inflation Reduction Act includes several provisions that will lower prescription drug costs for people with Medicare and reduce drug spending by the federal government. This brief summarizes these provisions and discusses the expected effects on people, program spending, and drug prices and innovation.| KFF
