Remove 2003 Remove Healthcare Remove Manufacturing Remove Provider
article thumbnail

To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

FDA Law Blog

The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the. And FDA did not provide a substantive response to 5 Requests for Advisory Opinions seeking clarification of the issue.

article thumbnail

Supreme Court Finds CMS’ Reduction of Medicare Hospital Outpatient Payment Rates for 340B Hospitals was Not Authorized by Statute

FDA Law Blog

The hospitals argued that the profits helped them offset the considerable costs of providing healthcare to the uninsured and underinsured in low-income and rural communities, something that Congress was well aware of and intended when it passed the Medicare Prescription Drug, Im­provement, and Modernization Act in 2003.