The FDA has issued a new rule to help with the drug shortage problem in an effort to make sure doctors and patients have the drugs when needed. The rule requires sole manufacturers of drugs to report any interruptions in production to the FDA. The rule is in line with President Obama’s Executive Order for the FDA to take action to reduce and prevent drug shortages. For more information from FierceBiotech, go here.
Obstacles Facing Biosimilars
Still in its infancy in the U.S., the industry faces some growing pains.
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