FMD K&L COVID-19 Update

by Andrei Shpak

COVID-19 continues to spread throughout the world and affect our communities. During this time, FMD K&L has taken measures to ensure the safety of our workforce while maintaining our commitment to our Valued Customers. FMD K&L continues to monitor the situation on a daily basis, taking guidance from the World Health Organization and the Centers […]

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Drug-Device Combo Development in China

by Andrei Shpak

Peng Zhao Sr. Regulatory Affairs Manager for the Medical Device Section at FMD Recently we have had a lot of interest in Drug-Device Combinational products and how to navigate such products through the regulatory system in China. The regulations on this type of therapeutics are less well defined, making it challenging to obtain appropriate approval […]

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Free Webinar: COVID-19 Risk Mitigation in Clinical Trials (recorded)

by Andrei Shpak

COVID-19 is ravaging the world. Collaboration of everyone involved in a trial is required. We hosted a webinar on April 2 to share information and lessons learned by sponsor, site, and CRO. During this webinar, three speakers addressed various aspects of the impacts and mitigation strategies to keep the trial going and to maintain integrity. […]

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Fountain Medical Appoints Mr. Ling Zhen as the Co-Chairman and Chief Executive Officer

by Andrei Shpak

Fountain Medical Development Limited (“Fountain Medical” or “Company”), a clinical service CRO dedicated to offering high-quality one-stop services to Pharmaceutical and Medical Device clients, announced today that Mr. Ling Zhen, J.D., M.B.A., is appointed as the Co-Chairman of the Board of Directors and Chief Executive Officer. Mr. Zhen has over 25 years of professional experience […]

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Cancer Hospital of China Academy of Medical Sciences (CHCAMS)

by Andrei Shpak

Huiyao Huang, PhD Epidemiology and Health statistics Academic Director of Clinical Trials Center of National Cancer Center, Cancer Hospital Chinese Academy of Medical Science. FMDView recently interviewed Dr. Huang Huiyao of the Cancer Hospital of China Academy of Medical Sciences (CHCAMS), one of the top academic hospitals in the country. Dr. Huang is the Academic […]

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Fountain Medical Development Limited, Parent Company of FMD K&L, Announces $62 mm Series D Round Financing, Further Strengthening its Global Services Capabilities

by Andrei Shpak

BEIJING and SHANGHAI , Oct. 24, 2019 /PRNewswire/ — Recently, Fountain Medical Development Limited (“Fountain Medical” or “Company”) announced its $62 mm Series D round financing. The investment was led by Goldman Sachs, with Lilly Asia Ventures as co-investor. Proceeds of the Series D financing will be used to fund the Company’s near term growth objectives. […]

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The long-awaited roll out of the enhanced drug Marketing Authorization Holder (MAH) program in China

by Andrei Shpak

Lei Liu VP of Regulatory Affairs of FMD As a part of the drug evaluation and approval reform in China, the enhanced Marketing Authorization Holder (MAH) system is now law in China nation-wide. This law eliminates a significant hurdle for drug developers in registering and marketing an innovative drug in China.

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New Accelerated Regulatory Paths in China

by Andrei Shpak

Lei Liu   VP of Regulatory Affairs of FMD At the end of August, China’s legislature finally approved the long-awaited Drug Administration Law. Capping the dizzying regulatory reform since 2015, the new law codifies many of the popular provisions, such as the 60-day IND default approval.

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Major Regulatory Changes: Excipients and Packaging in China

by Andrei Shpak

Stay Up-To-Date on New Industry Trends. FMDView is a periodic publication on drug development with keen interests in China. We publish short articles on regulatory, clinical management, drug safety and related subjects. The authors are mostly FMD colleagues who work on the front line of drug development. Sometimes we will have articles by leading investigators […]

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