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When is a Confirmatory Trial “Underway” or Conducted with “Due Diligence” Enough for Accelerated Approval? FDA Explains Its New Authorities

FDA Law Blog

Valentine We recently blogged about a new December 2024 draft guidance about accelerated approval (the December 2024 draft guidance). That post largely focused on endpoints as well as the broader context for when accelerated approval is appropriate.

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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

FDA Law Blog

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. FDAs application and use of accelerated approval has evolved dramatically since it was first developed by the Agency to help address the HIV/AIDS epidemic in the late 1980s.

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How To Fire a Client And Move On

ALPS

Sometimes when a lawyer calls in, there is a despondency in the voice that comes across loud and clear. The lawyer isn’t always aware of it; but usually by the time the call ends, that has changed. As I see it, since that’s what was driving the despondency, life is too short to stay in the game. ABA Model Rule 1.16

Lawyer 98
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6 Aspects of Attorney Departure Every Firm Must Know

ALPS

While good stuff, I suspect many attorney departures occur without anyone ever taking the time to pick up one of these books, if for no other reason than the lack of time. At all times, keep the interests of all impacted clients first and foremost in mind when making any departure-related decisions.

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Why It’s Worthwhile to Look for the Learning with Problem Clients

ALPS

When it comes to problem clients, we all have a story or two to share; but what if it becomes more than that? It can happen, and if and when it does, it’s time to stop and do a little problem solving. It’s time to look for the learning. It’s time to look for the learning.

Lawyer 98
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Guest post: Brazil will have first climate litigation trials in the Supreme Court

ClimateChange-ClimateLaw

This is an atypical situation in the Brazilian context: having a full day focused on environmental cases has never been done before, and emphasizes the deliberate effort of the Supreme Court to ensure an environmental agenda within the country. Brazill (on Amazon Fund) (ADO 59).

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Year in Review: Trademark Trends, Filings & Cases of 2021 – Part II

The Fashion Law

Chanel Files for the Number 5, Prada Pairs Down its Triangle. As we noted earlier this month, Chanel is aiming to bolster its robust arsenal of world-famous trademark registrations by way of an interesting mark. Huawei Prevails in the Trademark Case Waged Against it by Chanel. and internationally that are worth reflecting on.

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