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Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

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News

Appealing a denial of a drug/medical device export certificate: FDA final guidance

Drug and medical device manufacturers seeking to export a product from the United States may need to obtain from the U.S. Food and Drug Administration (FDA) a Certificate to Foreign...

News

China adds 30 drugs to its "urgently needed" list

Faster review periods and waiver of requirement for Chinese clinical trials are intended to encourage marketing applications

News

FDA, EMA Address Quality & Manufacturing Issues for Breakthrough Therapies with Expedited Approval

On July 31, 2019, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) published a joint report on their efforts to support the development of and expedite...

News

New FDA draft guidance on voluntary recalls highlights importance of recall initiation plans Focus on Regulation

On 23 April, Food and Drug Administration (FDA) issued draft guidance entitled "Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C," which aims to clarify how firms in a...

Hogan Lovells Publications

Good Manufacturing Practice and the global supply chain

Supply chain oversight: what to expect from —and how to prepare for— an increasingly global supply chain and heightened FDA scrutiny

News

U.S. Drug Inspections in China: Staying Ahead of FDA Enforcement Trends

China’s pharmaceutical manufacturing industry is amongst the largest, and, from a supply-chain perspective, one of the most important, in the world. One consequence of China’s...

Hogan Lovells Publications

U.S. drug inspections in China: Staying ahead of FDA enforcement trends

美国对华药品检查:值得重视的 FDA 最新执法趋势

News

FDA Shuts Down OTC Drug Manufacturer with Longstanding and Pervasive cGMP and Labeling Issues

On Tuesday, FDA announced the entry of a consent decree of permanent injunction against Keystone Laboratories, Inc. of Memphis, Tennessee for manufacturing OTC hair care and skin care...

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