The Process Street
JANUARY 8, 2021
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.
FDA Law Blog
JULY 10, 2023
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 Process Street
DECEMBER 25, 2020
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.
FDA Law Blog
SEPTEMBER 20, 2021
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.
FDA Law Blog
SEPTEMBER 27, 2023
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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