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Home » Nonclinical Safety Evaluations of Adjunctive Therapies Are Excessive, PhRMA Says
Nonclinical Safety Evaluations of Adjunctive Therapies Are Excessive, PhRMA Says
May 10, 2005
An FDA draft guidance that proposes manufacturers conduct nonclinical safety studies on drug combinations, including adjunctive therapies, is excessive and needs to be further clarified, PhRMA said in recent comments submitted to the agency.