An Overview Of Congress' Sweeping FDA Reforms

Law360, New York (July 2, 2012, 12:55 PM EDT) -- With a final overwhelming vote in the Senate, the U.S. Congress passed a U.S. Food and Drug Administration user fee bill that will provide necessary funds for the agency to perform drug reviews and require it to meet performance goals, as well as other important reforms. The Food and Drug Administration Safety and Innovation Act will be signed by President Barack Obama shortly.

Many provisions in this sweeping bill change existing review and approval rules and processes — especially for rare disease products and antibiotics. It...
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