FDA Law Blog
OCTOBER 24, 2023
On September 29, 2023, FDA released a draft guidance on Electronic Submission Template for Medical Device De Novo Requests. Unlike 510(k)s, using eSTAR for De Novos does not eliminate the acceptance review process, which must be conducted and completed within 15 calendar days of FDA receiving a De Novo request.
Broadcast Law Blog
FEBRUARY 27, 2023
At its March 16 regular monthly open meeting, the FCC will consider a draft Further Notice of Proposed Rulemaking (“FNPRM”) that, if adopted, would formally propose to extend the FCC’s existing audio description requirements for broadcast television to DMAs below the top 100 (i.e., DMAs 101-210). and 11:59 p.m. local time.
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FDA Law Blog
SEPTEMBER 20, 2021
Notable Dates and Timelines – Program opens, beginning of FY 2023; Expediting reviews fully implemented, by FY 2024; Webpage with detailed criteria for acceptance and participation, October 1, 2022; Interim assessment, end of FY 2025; Public workshop, end of Q2 FY 2026. Notable Dates and Timelines – Inspection tools draft guidance, by Sept.
Parasec
JULY 6, 2023
Nationwide: UCC Form Changes The International Association of Commercial Administrators (IACA), which drafts the Uniform Commercial Code (UCC) forms, has implemented changes to the UCC filing forms with a revised date of July 1, 2023. For more information, visit the “Don’t Be Misled” page here.
FDA Law Blog
DECEMBER 3, 2023
On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. Below, we provide a high-level summary of the Final Guidance, focusing on the legal and regulatory updates from the May 2023 draft guidance.
Broadcast Law Blog
FEBRUARY 26, 2023
The FCC released a draft Further Notice of Proposed Rulemaking (“FNPRM”) that, if adopted as scheduled at the FCC’s March 16 open meeting, would formally propose to extend the FCC’s existing audio description requirements for broadcast television to DMAs below the top 100 (i.e., local broadcasters to innovate and thrive. DMAs 101-210).
LawSites
DECEMBER 4, 2023
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