Industry/Agency Revolving Door Hits Spear In Nose, But Firm Relaunches ANDA
While Spear's generic fluorouracil is back on the market after a temporary restraining order expired June 18, the odyssey illustrates the risks to companies inherent in FDA relying on industry opinions during product review
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FDA's Decision-Making Process For ANDA Approval Standards Questioned In Vancomycin Case; Would Process Changes Alter The Outcome?
ViroPharma has fired another shot across FDA's bow in the continuing battle over approval standards for generic oral vancomycin, charging in a petition supplement that the Office of Generic Drugs' decision to change bioequivalence methods for this antibiotic "was fraught with irregularities.
Teva and Hospira halt shipments of oxaliplatin after an appeals court temporarily stays FDA approval of their ANDAs.
Legislative changes to the citizen petition process are forcing would-be petitioners to reevaluate when they should submit their petitions to the FDA