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This is the third topic included in the new draft guidance. Formal Dispute Resolution The draft guidance draws from the existing CDER and CBER guidance on formal dispute resolution (Existing FDR Guidance) with some significant differences.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