IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST?
As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more
On June 17, the Food and Drug Administration announced the establishment of the Commissioner's National Priority Voucher (CNPV) program. Although initial details are sparse, the CNPV promises fast action, allowing drug...more
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
Key Insights for Pharma Manufacturers Regarding the AKS - In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General...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