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Next-Gen Bar Exam That Truly Tests Daily Practice Skills Must Include Technology

LawTechnologyToday

“Professed technological incompetence is not an excuse for discovery misconduct” is not a court holding you want to see (James v. In today’s legal profession, lawyers must be technologically competent. Currently, most states have created the duty of technology competency by adopting some form of Model Rule 1.1 5, 2014)).

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The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law Blog

These alternative tools have included requesting records and other information from facilities/sponsors, using information and inspection reports from foreign regulatory authorities, and alternative technology platforms. Notable Dates and Timelines – Inspection tools draft guidance, by Sept.

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FDA Brings its Formal Meetings Guidance Up to Date: What You Need to Know About Type D, INTERACT, and “In-Person” Meetings Under PDUFA

FDA Law Blog

The Washington Nationals won the World Series, Presidential administrations have come and gone, and FDA has added new meeting types and formats to its menu. And so, FDA has issued a new draft guidance to bring everyone up to speed on formal meetings under PDUFA.

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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

FDA Law Blog

While formal meeting minutes are not mandatory for a 10-day call, it is beneficial to draft minutes and include them in the AI response. To ensure a comprehensive and timely response within the given 180-day timeframe, it is a good idea to begin drafting responses early on.