FDA Law Blog
SEPTEMBER 6, 2023
Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. We are not aware of a similar guidance for meeting requests from manufacturers of NDA drugs.
FDA Law Blog
DECEMBER 3, 2023
As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028.
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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.
Customs & International Trade Law
APRIL 29, 2022
Food and Drug Administration ( FDA ) announced the availability of a draft guidance for industry entitled The Accredited Third-Party Certification Program: Questions and Answers: Guidance for Industry. CBP officers determined that the rings had a total Manufacturers Suggested Retail Price (MSRP) value of approximately $15,000.
FDA Law Blog
DECEMBER 18, 2022
Mullen — On December 9, 2022, FDA issued a draft guidance document on the Voluntary Malfunction Summary Reporting (VMSR) Program for medical devices. The VMSR Program allows manufacturers to bundle malfunction reports of “like events” together in a single summary report. In that letter, FDA stated that it would “permit manufacturers.
MyCase
AUGUST 8, 2022
One of a SaaS lawyer’s most important duties is drafting and reviewing contracts and agreements. For example, if a software company wants to work with a new client, their lawyer can draft a SaaS agreement outlining the terms of the relationship. Contracts and Agreements . Renewals and auto renewals . Termination . Dispute resolution .
MyCase
AUGUST 8, 2022
One of a SaaS lawyer’s most important duties is drafting and reviewing contracts and agreements. For example, if a software company wants to work with a new client, their lawyer can draft a SaaS agreement outlining the terms of the relationship. Contracts and Agreements . Renewals and auto renewals . Termination . Dispute resolution .
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