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4 February 2013
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US regulators are coming under renewed scrutiny regarding their oversight of pharmaceutical compounders, with House legislators threatening to subpoena the US Food and Drug Administration for what
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11 January 2013
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The US Food and Drug Administration (FDA), which recently cleared two drugs using a unique regulatory pathway aimed at facilitating the development and approval of medical countermeasures and
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1 June 2012
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The Congressional Research Service, the House and Senate’s semi-private think tank, has released what it is calling a side-by-side comparison of the Senate’s Food and Drug Administration Safety and
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14 May 2012
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A report released by the Ombudsman’s Office of the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) for 2011 says smaller companies are contacting it more because they
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11 April 2012
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A group of six Republican Representatives sent the Commissioners of the US Food and Drug Administration (FDA) and the Federal Communications Commission (FCC) a letter cautioning the agencies against
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28 March 2012
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The US Food and Drug Administration (FDA) released new guidance on 27 March establishing Class II Special Controls for full field digital mammography systems (FFDMS), bringing the device class under
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8 March 2012
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The US Food and Drug Administration’s (FDA) Director for the Center for Drug Research and Evaluation (CDER), Janet Woodcock, testified before the House Energy and Commerce Committee on 8 March to
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28 February 2012
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The Medicines and Healthcare products Regulatory Agency (MHRA) issued advice to patients and surgeons urging them to monitor so-called metal-on-metal hip replacements on an annual basis for the
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9 January 2012
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The European Medicines Agency (EMA) today released a guideline titled, Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections. The document was approved last
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4 January 2012
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The Chinese State Food and Drug Administration (SFDA) today released an interim regulation titled, “Measures for Food and Drug Compliant Report.”The regulation aims to standardize the management of
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