Calendaring, Drafting, Meetings Minutes and Technology

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

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

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. Notable Dates and Timelines – Inspection tools draft guidance, by Sept.

Drafting

Drafting Manufacturing Meetings Minutes Technology

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 And so, FDA has issued a new draft guidance to bring everyone up to speed on formal meetings under PDUFA.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

Paralegal Brief

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

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

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

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