FDA Posts Investigator In Singapore, But Trims Foreign Office List
FDA's Office of International Programs consolidates its China offices to "strategically focus its resources." FDA shifts away from primarily a domestic focus to global as drug criminal organizations spread globally
Learn what's happening at the US FDA. On the go.
More from China
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With the US BIOSECURE Act waiting for a Senate vote, there are signs it may be prompting some Chinese firms to look at their operations. In the meantime, two legal experts in China suggest a range of coping strategies for companies that may be deemed "of concern."
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The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
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China’s top drug regulator is implementing a pilot program offering shorter review times for IND applications to improve the quality and efficiency of clinical studies and stimulate the country’s innovative drug sector.
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Shanghai issues a new set of policies and financial incentives designed to support and speed up regulatory and commercial activities in the biopharma sector, in a comprehensive stimulus package for companies based in the major Chinese city.
More from Asia
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Non-Japanese firms without offices in the country may submit documents for approval filings in English, subject to certain conditions.
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The Pink Sheet Drug Review Profile explores the US FDA’s approval of vadadustat to treat anemia in chronic kidney disease patients on dialysis. A complete response letter cited the risk of drug-induced liver injury, but postmarketing data from Japan reassured reviewers.
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Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
