Remove Calendaring Remove Meetings Minutes Remove Technology
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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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Office Hours: Top Tips on How to Create an Effective Open Door Policy for Your Remote Team

The Process Street

Because, with technological and digital progression, remote work is becoming common-place. Using this link, team members can pick meeting times of preference, and all events are added to your calendar automatically. I put my Calendly link in my Slack profile for anyone to grab it straight away and book it on my calendar.

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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

When you have daily status meetings, many people hold onto their updates until that meeting. Even if they finish the project the day before, the meeting becomes the deadline. Instead, use technology to keep teams updated throughout the day. How to improve this situation: Rely on your calendar system.

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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. Finally, FDA will hold a public workshop on meeting management.