LawTechnologyToday

APRIL 18, 2023

Basic technology tasks that fall under these categories include “draft initial report for client,” “draft resolutions, written consents, and/or meeting minutes,” and “draft engagement letter.” Since email is being drafted, the testing of mail merge skills can also be included in the exam.

Bar Exam 82

Bar Exam Technology Metadata Law School 82

FDA Law Blog

JUNE 21, 2021

Advice communicated in meeting minutes and other correspondences is not a regulatory action taken by CDER or CBER; therefore, it would not be an appropriate subject for a formal dispute resolution request (FDRR) by a sponsor.”).

Meetings Minutes 52

Meetings Minutes Drafting 52

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the pandemic and likely in acknowledgement of the potential for future travel restrictions, FDA plans to issue new draft guidance. Notable Dates and Timelines – Inspection tools draft guidance, by Sept.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 52

Drafting Manufacturing Meetings Minutes Technology 52

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 And so, FDA has issued a new draft guidance to bring everyone up to speed on formal meetings under PDUFA.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 64

Drafting Meetings Minutes Calendaring Manufacturing 64

FDA Law Blog

JULY 10, 2023

While formal meeting minutes are not mandatory for a 10-day call, it is beneficial to draft minutes and include them in the AI response. To ensure a comprehensive and timely response within the given 180-day timeframe, it is a good idea to begin drafting responses early on.

Calendaring 75

Calendaring Meetings Minutes Drafting Education 75

FDA Law Blog

JULY 4, 2023

This is the third topic included in the new draft guidance. Formal Dispute Resolution The draft guidance draws from the existing CDER and CBER guidance on formal dispute resolution (Existing FDR Guidance) with some significant differences. By Deborah L. A proposed order or an interim order is not an appropriate subject for an FDR.

Drafting 52

Drafting Meetings Minutes 52