FDA Withdraws Proposed Generic Drug Labeling Rule
The U.S. Food and Drug Administration recently announced it will withdraw a proposed rule that would have required generic drug manufacturers to independently update their drug labels with new...
View ArticleFDA Adds Useful Information to the ANDA Paragraph IV Certifications List for...
The U.S. Food and Drug Administration took another step to implement its Drug Competition Action Plan on June 18, 2019, by updating the information provided in the Paragraph IV Certifications List. The...
View ArticleFDA’s New MAPP Shows the Route to Changing Ownership of Generic Drug...
The U.S. Food & Drug Administration (FDA) recently issued a new Manual of Policies and Procedures (MAPP), in which it explains the Office of Generic Drugs’ (OGD) policy on facilitating changes to...
View ArticleCoordinating IP and Regulatory Filings Can Minimize the Risk of Inequitable...
On July 29, 2022, the U.S. Patent and Trademark Office (PTO) published a Notice on the Duties of Disclosure and Reasonable Inquiry During Examination, Reexamination, and Reissue, and for Proceedings...
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