Archive for June, 2024

The USPTO Proposes a Radical Change to Terminal Disclaimer Practice: You Have an Opportunity to Comment

On May 10, 2024, the United States Patent and Trademark Office (USPTO) issued a notice of proposed rulemaking that, if enacted, would tie the enforceability of every claim of a patent subject to a terminal disclaimer to the validity of any claim of the reference patent. In other words, if…

FDA Issues Overdue Draft Guidance on Clinical Trial Diversity Action Plans

Yesterday, the U.S. Food and Drug Administration (FDA) released its long-awaited draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. This draft guidance replaces the agency’s similarly-titled April 2022 draft guidance and has been issued to satisfy a requirement under the Food and Drug Omnibus Reform Act…

Form FDA 483 Response Best Practices Announced by the FDA

In Draft Guidance published this week by the U.S. Food and Drug Administration (FDA), Guidance for Industry – Processes and Practices Applicable to Bioresearch Monitoring Inspections, the Agency provides some wisdom on best practices for responding to Form FDA 483s, albeit in the context of its Bioresearch Monitoring (BIMO) program…