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Improving Import Safety

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(HHS: Washington) -- Last year, the United States imported more than $2 trillion worth of products, from roughly 825,000 importers, through more than 300 ports of entry.

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FDA Updates IT Infrastructure

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(FDA: Rockville, Maryland) -- In a bid to extensively modernize the Food and Drug Administration’s (FDA’s) data management, data warehousing, information technology (IT) infrastructure, and IT security, FDA has awarded 10 contractors a total of $2.5 billion to implement the FDA’s Informatio

Quality Control Breakdown at Ranbaxy Manufacturing Plants

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(FDA: Rockville, Maryland) -- Due to quality control problems at two Ranbaxy Laboratories Ltd. manufacturing plants in India, the U.S. Food and Drug Administration (FDA) issued two warning letters and an import alert for generic drugs produced by the company.

FDA Clinical Trial Conference

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(FDA: Dallas, Texas) -- The U.S. Food and Drug Administration (FDA) Dallas District, in cooperation with the Society of Clinical Research Associates (SoCRA), is holding a conference on FDA Clinical Trial Requirements Regulations, Compliance, and GCP.

Standardized Medical Imaging Forum

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(Drug Information Association: Horsham, Pennsylvania) -- The Drug Information Association (DIA), in collaboration with the U.S.

FDA Revises List of Recognized Standards

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(FDA: Rockville, Maryland) -- The U.S. Food and Drug Administration (FDA) has issued new revisions to its list of accepted standards for use in pre-market reviews of medical devices.

FDA New Policies Regarding Transparency

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(FDA: Rockville, Maryland) -- The Food and Drug Administration (FDA) plans to implement several improved policies and procedures strengthening its management advisory committees.

FDA Guidance Increases Drug Safety

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(FDA: Rockville, Maryland) -- The U.S.

Pharmaceutical Industry Addresses Drug Contamination

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(ASPEX: Pittsburgh, Pennsylvania) -- Following the U.S. Food and Drug Administration’s recent decision to join European and Australian authorities in the inspection of overseas drug manufacturing facilities, the pharmaceutical industry is re-examining its approach to quality control.

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