The Final Q-Sub Guidance provides comprehensive guidance on the Q-Sub process and finalizes the draft guidance regarding the Q-Sub program that was issued on March 15, 2024, with minimal changes from ...
On May 29, 2025, the U.S. Food and Drug Administration (FDA) issued a final version of its guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” ...
A new guidance document published by the US Food and Drug Administration (FDA) establishes and otherwise clarifies the process by which biopharmaceutical and medical device companies need to pay user ...
HOUSTON, TX, May 01, 2025 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (NXL) (Nasdaq: NXL; NXLIW) (the “Company” or “Nexalin”), today announced that it plans to submit a Q-Submission (“Q-Sub”) to the ...
Biogen (NASDAQ:BIIB) and Eisai (OTCPK:ESAIY) announced the rolling submission of a marketing application to receive an FDA label expansion for a subcutaneous autoinjector that delivers their Alzheimer ...
Indeed, many of the de novo petitions followed fairly lengthy 510 (k)s that failed to gain FDA clearance and so were converted to de novo submissions. More than just the delay in getting a response, ...
Senseonics, a Germantown, Maryland-based company working on a longterm implantable continuous glucose monitor, announced preliminary results from its US pivotal trial, a major step toward receiving ...
CTP Portal Next Generation also accepts Substantial Equivalence submissions. Step-by-step instructions on completing the forms; A more user-friendly interface that helps guide applicants through the ...
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