Prof. Niazi, filed a citizen petition demanding the FDA to withdraw the guidance to prevent vested interests from misguiding prescribers and patients that biosimilars have different safety and efficacy. The FDA has accepted the petition for review and designated it as FDA 2019-P-1236.
Read MoreIn an extraordinary move, the FDA has withdrawn the draft guidance, "Statistical Approaches to Evaluate Analytical Similarity,” after receiving public comments and one citizen petition (FDA-2018-P-1876).
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