Calendaring, Drafting and Meetings Minutes

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

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.

Calendaring

Calendaring Meetings Minutes Drafting Education

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

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 And so, FDA has issued a new draft guidance to bring everyone up to speed on formal meetings under PDUFA.

Drafting

Drafting Meetings Minutes Calendaring Manufacturing

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

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the pandemic and likely in acknowledgement of the potential for future travel restrictions, FDA plans to issue new draft guidance. Notable Dates and Timelines – Inspection tools draft guidance, by Sept.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.

Drafting

Drafting Manufacturing Meetings Minutes Technology

Paralegal Brief

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

FDA Brings its Formal Meetings Guidance Up to Date: What You Need to Know About Type D, INTERACT, and “In-Person” Meetings Under PDUFA

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

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