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