IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST?
Abbreviated New Drug Applications and 505(b)(2) Applications - This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug...more
This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more
The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, forms the current framework for the United States’ regulation of drug approvals. The law amended the Food, Drug, and...more
ANDA litigation is a high-stakes niche of pharmaceutical law that presents unique challenges not only for lawyers, but also for eDiscovery practitioners. Here’s why: under the Drug Price Competition and Patent Term...more
Hosted by American Conference Institute, the 20th Annual Paragraph IV Disputes & the 40th Anniversary of the Hatch-Waxman Act returns for another exciting year with curated programming that will take a retrospective look at...more
Agency works to speed approvals and improve access to generic prescription drugs. In recent weeks, the US Food and Drug Administration (FDA or the Agency) has taken a series of steps — under FDA Commissioner Scott...more