The federal government re-ignited a controversial proposal to give generic drug makers the power to unilaterally update product labels to reflect new safety information, a proposal that drew criticism ...
The Skinny Labels, Big Savings Act was introduced on January 9 in an effort to provide “a statutory safe harbor from patent ...
In a Hatch-Waxman case, the District Court for the District of New Jersey recently found that a generic label that included an allegedly infringing permissive use did not induce infringement where the ...
The Federal Circuit reversed a decision from the District of Delaware dismissing a case for failing to plead induced infringement because the totality of the evidence raised fact questions that could ...
America is in the midst of a pharmacy crisis, and the Food and Drug Administration could make it much worse. Hundreds of ...
Participants examined the challenges and opportunities to update oncology drug labeling that is inconsistent with the current evidence base and use in clinical practice. Discussions focused on what ...
The US Food and Drug Administration has updated the label of the diabetes drug Ozempic to acknowledge reports of blocked intestines in some people using the medication. Ozempic and its sister drug, ...
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