IPWatchdog

A Primer on Paragraph IV Certifications: Into the Belly of the Hatch-Waxman Beast Part 1

In a moment of extreme weakness, I agreed to Gene’s request to doing a primer on Paragraph IV Certifications under the Drug Price Competition and Patent Term Restoration Act, commonly referred to as ...
Health Affairs

Reforming The FDA’s Paragraph IV Requirement To Encourage Faster Generic Drug Entry

The Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act, established a pathway for the approval of generic drugs. Under this act, manufacturers ...
IPWatchdog

FDA rules updated on patent information, paragraph IV certifications for ANDAs and 505(b)(2) applications

On Thursday, October 6th, the U.S. Food and Drug Administration (FDA) published a 79-page notice in the Federal Register regarding new rules surrounding Abbreviated New Drug Applications (ANDAs) and ...