FDA Commissioner Hamburg: “We Want to Work With the 510(K) Process”

Pharmaceutical and medical device companies have long grumbled about the U.S. Food and Drug Administration‘s process for getting new products approved. Some say it’s too long. Others say it’s restrictive. Many say it’s just not clear.FDA Commissioner Dr. Margaret Hamburg heard many of those concerns in person during a visit to North Carolina’s Research Triangle. In addition to meeting with several life sciences companies and business leaders, Hamburg toured the new Novartis (NYSE:NVS) vaccine plant in Holly Springs, North Carolina.

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