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Office Hours: Top Tips on How to Create an Effective Open Door Policy for Your Remote Team

The Process Street

Using this link, team members can pick meeting times of preference, and all events are added to your calendar automatically. “ I book all my recurring meetings Monday-Thursday and try to leave Friday open for people to book in with me if they need/want to. . Meeting minutes provide transparency and accountability.

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

FDA Law Blog

FDA Day (in calendar days) FDA Actions Day 1 FDA receives 510(k) submission. A best-case scenario for a firm would be that FDA does not place the submission on hold and clears it within 90 total calendar days (or less) to reach the SE decision. Note that days are in calendar days. Note that the FDA clock uses calendar days.

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The Key to Productive Meetings? Cancel Them! 7 Meetings to Scrap

The Process Street

What if the first meeting runs long and you have to jump off a call or move conference rooms to quickly get to the next meeting? How to improve this situation: Rely on your calendar system. Check each participants’ calendars and see what meetings are taking place that day. Ray Dalio’s Meeting Process.

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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

FDA intends to respond to a Type D meeting request within 14 days from receipt and to schedule a meeting or issue written responses within 50 days of receipt of a request. FDA intends to provide preliminary responses to Type D meeting packages no later than 5 calendar days before the meeting date.

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

FDA Law Blog

This memorializes a more recent practice adopted by the Agency given the increased use of WRO meetings during the COVID-19 pandemic, allowing follow-up questions to clarify the Agency’s feedback in a WRO or something captured in meeting minutes. Finally, FDA will hold a public workshop on meeting management.