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New Developments in China’s Drug Change Management Regulations

Arnold Porter

The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) recently released the Acceptance Review Guideline on Biological Products Changes (for Trial Implementation). Latest Developments in China’s Drug Change Management Regulations. ???????????????. “????”???????????????????????????????????????2019?????????????20???????????????????????????????????????????????????????????.

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FDA Seeks to Deepen Engagement with USPTO on Pharmaceutical Patents

Arnold Porter

On September 10, 2021, the Acting Commissioner of the Food and Drug Administration (FDA), Janet Woodcock, published a letter to the US Patent and Trademark Office (USPTO) seeking increased exchange and collaboration between the two agencies relating to grants of patent rights to pharmaceutical innovations.

Law 97
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Antitrust Agency Insights: Developments at the US Antitrust Enforcement Agencies—Fourth Quarter 2022

Arnold Porter

N: See Policy Statement of the Federal Trade Commission on Rebates and Fees in Exchange for Excluding Lower Cost Drug Products (Jun. 16, 2022), available here and FTC Press Release, FTC Launches Inquiry Into Prescription Drug Middlemen Industry (Jun. A trial on the issue is currently set to begin April 2023. Read the Complaint.

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