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FDA Approval › Due Diligence › Food and Drug Administration (FDA)

Gardner Law

[Hybrid Event] Due Diligence Decoded: M&A Success in FDA-Regulated Industries - September 20th, Boston, MA

Gardner Law on

Join Gardner Law for a half-day CLE event in person at Loft on Two in Boston, MA or attend virtually. Industry experts will decode the intricacies of regulatory scrutiny and strategic decision-making in acquisitions. Gain...more

Knobbe Martens

Navigating the Regulatory Landscape: FDA Approval and Patent Protection for Software as a Medical Device

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Software is increasingly used as a medical device, transforming the healthcare industry with the goal of improving patient outcomes. However, developing software as a medical device involves navigating complex and evolving...more

Troutman Pepper

Due Diligence: Calculating the Regulatory Review Period for Patent Term Extension

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This is the fourth article in our five-part series on PTE. When applying for a patent term extension (PTE), due diligence matters. If an applicant did not act with due diligence during the testing phase or the approval...more

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