Search Results for keywords:"due diligence"

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Search Results: keywords:"due diligence"

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  • 2024-31023 — Determination of Regulatory Review Period for Purposes of Patent Extension; XTAMPZA ER
    Type:Notice
    Citation:89 FR 106507
    Reading Time:about 7 minutes

    The Food and Drug Administration (FDA) has determined the regulatory review period for the drug XTAMPZA ER, which is used for managing severe pain requiring long-term opioid treatment. This review is necessary for a possible extension of the drug's patent, as requested by Collegium Pharmaceutical, Inc. The review period comprises 3,214 days, with 2,712 days for testing and 502 days for approval. The FDA invites comments on this determination and allows for petitions if there are disagreements concerning the information or the due diligence during the review process.

    Simple Explanation

    The FDA checked how long it took to approve a special medicine called XTAMPZA ER, used for pain, to see if they can give it more time before others can copy it. People can say if they agree or disagree with how the FDA measured this time.

  • 2024-31022 — Determination of Regulatory Review Period for Purposes of Patent Extension; NEXOBRID
    Type:Notice
    Citation:89 FR 106508
    Reading Time:about 7 minutes

    The Food and Drug Administration (FDA) has announced the regulatory review period for NEXOBRID, a product used for eschar removal in adults with certain types of burns. This review period is relevant to an application for patent term extension submitted to the U.S. Patent and Trademark Office (USPTO) by MediWound, Ltd. The FDA determined that the total regulatory review period for NEXOBRID was 7,427 days, with a request for a 5-year patent extension being made. The public can submit comments on this determination until February 28, 2025, and may petition the FDA to review whether the applicant acted with due diligence during this period by June 30, 2025.

    Simple Explanation

    The FDA decided how long it took to review a special medicine called NEXOBRID, used to help treat burns, and said it was nearly 20 years. They gave the company a chance to ask for more time on their patent so they can keep selling it without others copying it.