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  • Owe FDA Money? Don't Bother Submitting an Application, Says CDER

    A new Manual of Policies and Procedures (MAPP) document issued by the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) notes that if a pharmaceutical manufacturer is in arrears to FDA, CDER "shall refuse to accept the application for filing." FDA's MAPP 60.50.1 Rev. 1, Refusal to Accept Applications for Filing From Applicants in Arrears , notes "It is the general policy of CDER that human drug applications and supplements will be ...
  • Debt Levels Could Drive Pharma Companies Out

    • 23 February 2012
    Increasing debt at hospitals in Greece are threatening drug supplies and may force some companies out of business, according to a Greek pharmaceutical association. PMLive Intelligence reports the Hellenic Association of Pharmaceutical Companies is warning that hospitals run by the national social security organization in Greece have already run up debts of €500 million. This news comes at a time when the country is seeking a bailout package from the EU to prevent ...