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In it latest batch of Warning Letters, FDA cites Barry Eppley, Medisurg Research, Pascal, Pointe Scientific, and Sonotech.[ Price : $8.95]
FDA tells Wyeth that recently resubmitted raw data would require a three-month review extension of its NDA for desvenlafaxine succ...[ Price : $8.95]
CBER Office of Compliance and Biologics Quality director Mary Malarkey reviews top inspection findings at an industry conference.[ Price : $8.95]
The National Research Center for Women & Families says a study of 11 FDA advisory committees finds they often rubber stamp drug an...[ Price : $8.95]
FDA issues a guidance on emergency research when an exception from informed consent requirements is requested.[ Price : $8.95]
FDA questions whether there are adequate data to support approval of Adeza Biomedicals NDA for Gestiva, indicated for preventing p...[ Price : $8.95]
FDA denies an Epix Pharmaceuticals appeal request to approve its blood-pool imaging agent Vasovist.[ Price : $8.95]
Hailing the products economic benefits, FDA approves the first generic versions of Bayers Cipro IV Injection.