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Galactic Foresight Required: NASA's Proposed Rule Limits Advance Waivers to Yet-to-Be-Conceived Inventions

Client Alert | less than 1 min read | 10.23.14

Earlier this month, NASA proposed to amend its patent regulations to require contractors requesting an advance waiver of the government's domestic rights in inventions made under a NASA contract to identify with specificity any inventions or classes of inventions that the contractor "believes will be made under the contract." Thus, in order to obtain an effective waiver, the contractor must predict what "inventions or classes of inventions" the contractor might make under aNASA contract, which, given the unpredictable nature of R&D efforts, may not cover the inventions that the contractor actually develops.


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Client Alert | 2 min read | 05.09.25

FDA Seeks Stakeholder Consultation on Prescription Drug User Fee Reauthorization

On May 8, the U.S. Food and Drug Administration (FDA) took steps to begin the process for reauthorizing the Prescription Drug User Fee Amendments (PDUFA) by announcing a public meeting to be held on July 14, 2025. The agency invited public stakeholders, including patient and consumer advocate groups, health care professionals, and scientific and academic experts to participate in the meeting and subsequent public meetings to consult on the PDUFA reauthorization....