SKINVIVE Patent Extension Gets Its FDA Review Period
Published Date: 5/14/2025
Notice
Summary
The FDA has set the official review period for SKINVIVE, a medical device, so its patent holder can apply for extra patent time. If you think the dates are wrong or want to challenge the patent holder’s effort during review, you have until mid-2025 to speak up. This affects the company behind SKINVIVE and could impact how long they keep exclusive rights to their invention.
No Economic Impacts Identified for this Document
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-20848, Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods
The FDA is changing food rules to allow salt substitutes in many standardized foods, helping companies make lower-sodium options. This move aims to cut heart disease risks by reducing sodium without changing how foods basically taste or look. The new rule kicks in December 14, 2026, and food makers have until November 12, 2026, to raise any concerns, with no big costs expected.
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2025-04978, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA is delaying a new rule about nonprescription drugs that have extra conditions for use. Originally set to start on March 21, 2025, the rule’s start date is now pushed back to May 27, 2025, to allow more time for review. This affects drug makers and consumers by giving everyone extra time to prepare for the new requirements without any immediate cost changes.
2025-01840, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA’s new rule about nonprescription drugs needing extra conditions before use was set to start on January 27, 2025, but it’s now delayed until March 21, 2025. This delay follows a presidential order to pause and review new rules before they take effect. Drug makers, sellers, and consumers should note the new start date and get ready for the updated rules soon.
Previous / Next Documents
Previous: 2025-08448, Proposed Collection; Comment Request; Extension: Rule 18a-3
The SEC wants to keep Rule 18a-3 going, which helps nonbank security-based swap dealers keep an eye on risky trades and follow safety rules. About 13 dealers spend around 60 hours a year making sure everything’s in check, so the paperwork and time stay about the same. No big changes or costs, just a smooth extension to keep the financial playground safe and sound.
Next: 2025-08450, Determination of Regulatory Review Period for Purposes of Patent Extension; EPKINLY
The FDA has officially set the review period for EPKINLY, a human biological product, which helps the company extend its patent protection. If anyone thinks the dates are wrong, they have until July 14, 2025, to speak up. Also, people can challenge whether the company acted quickly enough during the review by November 10, 2025. This affects patent holders and could impact how long they keep exclusive rights to their product.