2007, Manufacturing and Utilities

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2007

Manufacturing

Utilities

Skinny Label and Induced Infringement: The Saga Continues

FDA Law

MAY 11, 2023

Specifically, the Government explained, “[t]he section viii pathway cannot function properly if FDA and generic manufacturers cannot rely on an NDA holder’s representations to the agency regarding which portions of the brand-name drug’s labeling teach patented methods of use.”

Government

Government Manufacturing IT Utilities

FDA-Approved Labeling: Is Enough Enough?

FDA Law

AUGUST 21, 2023

FDA did, however, try to identify safety issues through the medical literature and (after 2007 when mandatory safety reporting for OTC human drug products marketed without an approved application became effective) through the adverse event reporting system. Just like it was over a decade ago in Pliva v. Take, for example, sunscreens.

Manufacturing

Manufacturing Consulting Healthcare Professional IT

Primary Care Digest

Skinny Label and Induced Infringement: The Saga Continues

FDA-Approved Labeling: Is Enough Enough?

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