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Home » LEGAL CHALLENGES ABOUND ON 505(b)(2) PATHWAY, SAYS PFIZER
LEGAL CHALLENGES ABOUND ON 505(b)(2) PATHWAY, SAYS PFIZER
April 2, 2004
The FDA’s policy of relying on clinical trial data from approved drugs to OK 505(b)(2) generic drug applications is almost certain to be challenged in the courts in the future, according to a Pfizer attorney.