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Device manufacturers in China should integrate cybersecurity risk management into their quality management systems, according to new guidance from the China Food and Drug Administration. Read More
Former FDA deputy commissioner Scott Gottlieb emerged as the favorite to serve as the next leader of the FDA in a survey of 53 pharmaceutical companies. Read More
The FDA’s recently released final guidance on GMP requirements for combination products includes several compliance scenarios for prefilled syringes, drug-coated meshes and drug-eluting stents. Read More
The EU’s new medical device regulations nearing final approval will require more robust quality management systems, including the use of unique device identifiers and tighter control over distribution chains. Read More