US Regulation
Total 56 Posts
FDA Advisers Request More Data for Drug Trialed in China, Citing Lack of Diversity and Different Standards
Recently, an advisory committee of the U.S. Food and Drug Administration voted in favor of requiring additional trial data in order for a China-trialed medicine to obtain FDA approval. This decision could have major implications for future regulatory approval applications for medicines developed in China. The FDA's
FCC Revokes China Unicom Americas' Telecom Services Authority
Last week, the U.S. Federal Communications Commission (FCC) revoked the authority that had previously been granted to China Unicom to operate certain telecom services in the United States. The decision to revoke came after a full investigation, and similar actions could be taken against additional services offered by China
Department of Homeland Security Seeks Guidance on Preventing Importation of Goods Made With Forced Labor in China
In a Federal Register notice to be published on January 24, the U.S. Department of Homeland Security, on behalf of the Forced Labor Enforcement Task Force (FLETF), is seeking input from the public on "how best to ensure that goods, wares, articles, and merchandise mined, produced, or manufactured
SEC Finalizes Rules to End the Trading of Chinese Company Shares in the U.S.; China Remains Optimistic that a Solution Is Possible
On December 2, the U.S. Securities and Exchange Commission (SEC) finalized the
rules [https://www.sec.gov/rules/final/2021/34-93701.pdf] on disclosure
requirements for Chinese companies in relation to audit reports issued by
foreign accounting firms that the U.S. government does not have access to. While
FCC Sets Out Application Details for Reimbursement of Removal and Replacement of Chinese Telecoms Equipment
As we reported
[https://www.chinatrademonitor.com/fcc-program-for-removal-and-replacement-of-chinese-telecoms-equipment-moves-forward/]
in July, the U.S. Federal Communications Commission (FCC) has moved ahead with a
plan for reimbursing telecoms companies for the cost of removing, replacing, and
disposing of communications equipment that "poses an unacceptable risk to
national security," targeting equipment
New SEC Rules Further Curb Chinese Companies’ IPOs
After the recent saga involving Chinese company Didi, which was subject to
investigations
[https://www.chinatrademonitor.com/china-tightens-data-security-scrutiny-on-technology-companies/]
by Chinese regulatory authorities only a couple of days after going public in
the United States, the U.S. Securities and Exchange Commission (SEC) is
tightening rules for Chinese companies who try
FCC Program for Removal and Replacement of Chinese Telecoms Equipment Moves Forward
On July 13, the U.S. Federal Communications Commission (FCC) adopted
[https://www.fcc.gov/document/fcc-acts-protect-national-security-communications-supply-chain-0]
an order [https://docs.fcc.gov/public/attachments/FCC-21-86A1.pdf] that updates
the rules on reimbursing telecoms companies for the cost of removing, replacing,
and disposing of communications equipment that "poses an