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To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

FDA Law Blog

The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the. But it is not always clear which types of patents are eligible for listing in the Orange Book. The FDA Commissioner is quoted as saying that “[t]he FDA stands ready to assist the FTC.

Drugs 105
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Conducting a Biopharmaceutical Freedom-to-Operate (FTO) Analysis: Key Considerations for Generic Drug Stability Testing

Drug Patent Watch

Unlocking the Path to Generic Drug Development: A Freedom to Operate Analysis As a generic drug manufacturer, navigating the complex landscape of biopharmaceutical development can be daunting. But what exactly is an FTO analysis, and why is it essential for your generic drug stability testing?