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FDA publishes a draft guidance on possible enforcement discretion so dietary supplement companies can correct past failures to sub...[ Price : $8.95]
CDER Office of Pharmaceutical Quality director Michael Kopcha says the agency is working on regulations to help companies become m...[ Price : $8.95]
CDRH announces a new 510(k) Sterility Change Master File Pilot Program that is intended to give interested companies that terminal...[ Price : $8.95]
FDA publishes a draft guidance to help develop, maintain, and implement risk management plans to assist in preventing human drug s...[ Price : $8.95]
FDA principal deputy commissioner Janet Woodcock explains the components of the agencys new Enterprise Modernization Action Plan.[ Price : $8.95]
FDA updates its communications about Philips Respironics recalls of ventilators and BiPAP and CPAP machines.[ Price : $8.95]
Three medical device stakeholders express support for a proposed FDA change to the quality system regulation to incorporate an int...[ Price : $8.95]
Public Citizens Sidney Wolfe and Weill Cornell Medical College professor Martin F. Shapiro urge medical journals to step up their ...