NEWS AND VIEWS FROM THE PHARMACEUTICAL FINE CHEMICAL AND CUSTOM MANUFACTURING SECTOR

Thursday 22 March 2012

Manufacturing oversight bill proposed in US

In an effort to improve the tracking of drugs imported into the US, Senator Michael Bennet has published a discussion draft of a bill that would strengthen manufacturer quality standards by improving tracking of foreign manufacturing sites and requiring all manufacturers to register with FDA. The Senator also proposes that manufacturers submit information on the regulatory status, facility information, cGMP and "any other information deemed necessary" for imported drugs before entering the country.
US Senate

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