26 Aug 2025

💊FDA Notice on Regulatory Review Period and Patent Extension for PIASKY

Determination of Regulatory Review Period for Purposes of Patent Extension; PIASKY

Summary

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for PIASKY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

Agencies

  • Health and Human Services Department
  • Food and Drug Administration

Business Impact ?

$$$ - High

The document discusses the regulatory review period for a human biological product, PIASKY, and its implications for patent extension, which directly affects business owners in the pharmaceutical sector. Compliance with patent law and potential for financial gain from extended patents are critical points for executives in related industries.

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