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Comments Sought on Dietary Supplement GMP Recordkeeping

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Federal Register Notice: FDA announces an opportunity for public comment on information collection related to an extension of Curr...

Notice on West Nile Virus Guidance Corrected

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Federal Register Notice: FDA corrects a 9/13 notice on the availability of a guidance on Use of Nucleic Acid Tests To Reduce the R...

Notice on Biosimilar Public Meeting Corrected

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Federal Register Notice: FDA corrects a 9/19 notice on Biosimilar User Fee Act; Public Meeting to correct a date reference when th...

FDA Clears Becton Dickinson Plasma Blood Collector

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FDA clears a Becton Dickinson 510(k) for the BD Vacutainer Barricor plasma blood collection tube, a next generation blood collecti...

Information Security Weaknesses in 7 FDA Systems: GAO

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FDA says it has implemented 12 of 15 GAO recommendations for tightening its cybersecurity covering seven agency systems.

Group Wants Triclosan Banned from Toothpaste

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The Cornucopia Institute urges FDA to ban the use of triclosan in toothpaste, as it did in hand soaps earlier this month.

Labeling Options for Medical Device Symbols

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Two CDRH officials say that a new final rule on using symbols in medical device labeling gives manufacturers more options.

Comments on Quality Metrics Technical Guidance

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Five stakeholders provide comments and suggestions to FDA on a draft guidance on quality metrics technical conformance.

Duke Center Sets Medical Device Priorities

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Duke Universitys National Evaluation System for health Technology says its new coordinating center is to implement a national syst...

Concern Over FDA Medical Reviewer Revolving Door

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Researchers say they are concerned about the number of FDA medical reviewers who leave the agency to work for industry.