Notice
29 Jul 2025
compliance, regulations, fda, health, food, medical devices, drug
📄FDA Information Collection Approvals and Business Implications
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
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Notice
20 Jun 2025
fda, regulatory review, pharmaceutical, patent extension, velsipity, drug
💊FDA Notice on Regulatory Review Period for VELSIPITY Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VELSIPITY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application 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 drug product.
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