article thumbnail

The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law Blog

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.

article thumbnail

3 in 1 Guidance Issued by FDA Covering Formal Dispute Resolution, Administrative Hearings and Consolidated Proceedings for OTC Monograph Drugs

FDA Law Blog

By Deborah L. A proposed order or an interim order is not an appropriate subject for an FDR.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Amendment of Chinese Civil Procedure Law Concerning Foreign Affairs

Conflict of Laws

On one hand, the mature provisions in previous judicial interpretations, court meeting minutes, and other documents have been elevated to law, providing a more solid legal basis for the court’s jurisdiction and service of foreign-related cases.

article thumbnail

Next-Gen Bar Exam That Truly Tests Daily Practice Skills Must Include Technology

LawTechnologyToday

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.” Prieto, What’s New with the NextGen Bar Exam?