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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
Dozens of healthcare organizations, including several device makers, wrote an open letter to President Donald Trump urging him and Congress to continue the pursuit of value-based care. Read More