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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

FDA advises drug manufacturers on best practices for restarting operations during COVID-19 pandemic

On September 11, the U.S. Food and Drug Administration (FDA) issued a temporary guidance, “Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public...

News

FDA updates industry on what drug & biologic inspections will occur during COVID-19 pandemic

On Wednesday, August 19, the U.S. Food and Drug Administration (FDA) issued guidance providing some additional insight into how the agency will determine what drug and biologic inspections...

News

FDA to restart domestic inspection program using new Advisory Rating system

The U.S. Food and Drug Administration (FDA) said Friday it plans to resume on-site inspections of FDA-regulated facilities and other associated activities the week of July 20, 2020. The...

News

New FDA inspection program released for “streamlined approach” for combination product cGMP

On June 4, 2020, the U.S. Food and Drug Administration (FDA) updated the Compliance Program Guidance Manual (CPGM) to include a program for “Inspections of CDER-led or CDRH-led...

News

Five key takeaways from the Senate hearing on FDA oversight of foreign drug manufacturing

The pharmaceutical supply chain is extremely complex and relies on manufacturing sites located throughout the world. The COVID-19 pandemic has placed significant strain on this complex...

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...

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...

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...

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