As part of efforts to increase transparency and generic drug competition, the US Food and Drug Administration (FDA) is publishing patent submission dates to help generic drug manufacturers determine ...

For more than two years, the U.S. Federal Trade Commission (FTC) has been taking certain drugmakers to task over their alleged listing of "improper" patents in an FDA registry, a practice the agency ...

The US Food and Drug Administration has published a final draft guidance that addresses what’s expected when sponsors get complete response letters (CRL) to their abbreviated new drug applications ...

On Friday, June 21, 2024, the FDA updated its Patent Listing Dispute List to indicate that the ten pharmaceutical companies who had received warning letters from the FTC in April did not make changes ...

Verification of clinical benefit following FDA accelerated approval in oncology: A time-to-event analysis. This is an ASCO Meeting Abstract from the 2026 ASCO Annual Meeting I. This abstract does not ...

The tension between regulatory compliance and antitrust exposure in Orange Book patent listings reached a dramatic inflection point this fall. In late October, Teva Pharmaceuticals agreed to pay $35 ...

To advance policies that secure the future of a leading U.S. innovative industry, it is important in this instance to gain a deeper understanding of what generic drugs are, what the FTC is challenging ...

Biofrontera Inc. announced that it has received patent approval for a revised formulation of its Ameluz® nanoemulsion gel, which is now listed in the FDA's Orange Book, ensuring patent protection ...