FDA Law Blog

SEPTEMBER 20, 2021

When FDA published the fiscal years (FY) 2023-2027 goals letter at the end of August, making known their commitments and planned initiatives for the coming years, we were both excited by many of the announcements, while recognizing the real success will come from how the Agency implements them.

Drafting 52

Drafting Manufacturing Meetings Minutes Technology 52

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This is the third topic included in the new draft guidance. Formal Dispute Resolution The draft guidance draws from the existing CDER and CBER guidance on formal dispute resolution (Existing FDR Guidance) with some significant differences.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

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