The intersection of patent strategy and FDA regulatory strategy is a critical consideration for medical device companies. A well-integrated approach can create powerful barriers to entry, strengthen ...
To promote generic competition, the Hatch-Waxman Act established a pathway through which the U.S. Food and Drug Administration (FDA) may approve an abbreviated new drug application (ANDA) for a ...
The federal government urged the US Supreme Court to hear an appeal from Hikma Pharmaceuticals USA Inc. challenging an ...
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