Above The Law

MAY 27, 2025

Sam argued for a rebalancing of priorities in legal education: What to Drop: Practice-specific skills like drafting corporate meeting minutes or wills. Reimagining Legal Education: What Stays, What Goes The skills gap isnt just a problem for law studentsits an issue at every stage of a legal career.

Education 92

Education Legal Legal Technology 92

Conflict of Laws

APRIL 28, 2025

Hybrid) For the zoom link and previous meeting minutes, please refer to the project webpage Critical Minerals Traceability and Sustainability. The 3rd Working Group Meeting on Addressing Conflict of Laws and Facilitating Digital Product Passports in Cross-Border Value Chain, 12-1:00 pm Wednesday, 19 Feb 2025 (Sydney Time) Prof.

Meetings Minutes 45

Meetings Minutes Laws Drafting Legal 45

FDA Law

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 And so, FDA has issued a new draft guidance to bring everyone up to speed on formal meetings under PDUFA.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

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.

Meetings Minutes 98

Meetings Minutes Drafting Technology 98

FDA Law

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

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This is the third topic included in the new draft guidance. Formal Dispute Resolution The draft guidance draws from the existing CDER and CBER guidance on formal dispute resolution (Existing FDR Guidance) with some significant differences.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

FDA Law

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the pandemic and likely in acknowledgement of the potential for future travel restrictions, FDA plans to issue new draft guidance.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