Calendaring Drafting Meetings Minutes 
FDA Law Blog
SEPTEMBER 27, 2023
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 And so, FDA has issued a new draft guidance to bring everyone up to speed on formal meetings under PDUFA.
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.
FDA Law Blog
SEPTEMBER 20, 2021
Informed by experiences during the pandemic and likely in acknowledgement of the potential for future travel restrictions, FDA plans to issue new draft guidance. Notable Dates and Timelines – Inspection tools draft guidance, by Sept. The PFDD meeting initiative, including its expanded externally-led PFDD meeting program, continues on.
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