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 And so, FDA has issued a new draft guidance to bring everyone up to speed on formal meetings under PDUFA.
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This is the third topic included in the new draft guidance. Formal Dispute Resolution The draft guidance draws from the existing CDER and CBER guidance on formal dispute resolution (Existing FDR Guidance) with some significant differences.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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FDA Law Blog
JUNE 26, 2024
30 minutes or one hour) and type of meeting (i.e., In addition, the applicant is required to provide a draft agenda with an estimated time for each item on the agenda. The agenda at this point is usually quite general, with specifics added after receipt of FDA’s written feedback ahead of the meeting.
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.”).
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the pandemic and likely in acknowledgement of the potential for future travel restrictions, FDA plans to issue new draft guidance. Notable Dates and Timelines – Inspection tools draft guidance, by Sept.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.
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.
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.
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