FDA Release of Complete Response Letters Raises Confidentiality, Disclosure Questions But Offers Insights for Development
On July 10, 2025 — in a move it characterized as “radical transparency” — the U.S. Food and Drug Administration (FDA or Agency) published over 200 Complete Response Letters (CRLs), which are issued when the Agency determines that it will not approve a New Drug Application (NDA) or Biologics License Application (BLA). We analyze the implications of this development for life sciences companies and their investors.
Pharma Companies in Beijing Free Trade Zone to Benefit from Relaxed Data Transfer Rules
On August 30, 2024, the Beijing Municipal Cyberspace Administration, Beijing Municipal Commerce Bureau and Beijing Municipal Government Services and Data Administration Bureau jointly released the “Administrative Measures for the Data Exit Negative List of the China (Beijing) Pilot Free Trade Zone (Trial)” (Administrative Measures) and the “Data Exit Administration List (Negative List) of the China (Beijing) Pilot Free Trade Zone (2024 Edition)” (Negative List) to facilitate the export of important industry data and personal information out of the country by companies operating in the Beijing free trade zone (FTZ). (more…)
New Export Controls on Advanced Computing and Semiconductor Manufacturing: Five Key Takeaways
On October 25, 2023, the U.S. Department of Commerce Bureau of Industry and Security (BIS) published updated export controls on advanced computing items and semiconductor manufacturing equipment under the Export Administration Regulations (EAR). Specifically, BIS published two interim final rules that revise and expand on the restrictions implemented in the initial interim final rule issued on October 7, 2022 (October 7, 2022 rule).1
