Many local governments shrug off FDA warning about Canadian drug imports

7 March 2019 - Cities and local governments in several states said they will continue to use a Canadian company ...

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Statement from FDA Commissioner on ongoing efforts to stop the spread of illicit opioids, further secure the U.S. drug supply chain and forcefully confront opioid epidemic

12 February 2019 - The opioid epidemic continues to be one of the greatest challenges facing this nation and the FDA.  ...

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Fake drugs could put patients at risk after no-deal Brexit

8 February 2019 - Patients could be put at risk from fake medicines if the UK exits the EU without ...

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New safety features for medicines sold in the EU

8 February 2019 - As of 9 February 2019, most prescription medicines and some over-the-counter medicines for human use supplied ...

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FDA takes new steps to adopt more modern technologies for improving the security of the drug supply chain through innovations that improve tracking and tracing of medicines

7 February 2019 - A key element of the U.S. FDA’s mission is focused on helping to ensure that all ...

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Risk classification of antimicrobials used in animals opens for public consultation

5 February 2019 - EMA has published today for public consultation its updated scientific advice on the categorisation of antimicrobials.  ...

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FDA statement from Commissioner announcing efforts to improve the quality of the information used to assess the effectiveness of REMS programs in supporting the safe use of medications

24 January 2019 - In making decisions about whether the benefits of a drug outweighs its risks, there are many ...

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FDA issues letter about paclitaxel coated balloons and eluting stents

17 January 2019 - Today the FDA issued a letter to health care providers about a recent publication in the Journal ...

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Health Canada restricts Allergan's Esmya

15 January 2019 - Health Canada has placed restrictions on Allergan's uterine fibroid treatment Esmya, after discovering a possible link ...

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The future of FDA's electronic safety surveillance

9 January 2019 - The U.S. FDA is an information-driven agency that requires robust data to make regulatory decisions.  ...

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CDER’s work to ensure drug safety is an ongoing top priority

8 January 2019 - Yesterday, I reflected on the FDA’s Center for Drug Evaluation and Research’s wide array of new ...

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Statement from FDA Commissioner and Director of the Center for Devices and Radiological Health on transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices

26 November 2018 - Forty-two years ago, Congress passed the law establishing the framework for evaluating the safety and effectiveness of ...

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Database tracks faulty medical devices across the globe

26 November 2018 - Patients across the world now have access to facts about faulty or dangerous medical devices — ...

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Dangerous medical devices let through by loopholes and lax regulation

26 November 2018 - The New Orleans sales conference of medical-device maker DePuy Orthopaedics Inc. was rocking. The sound system ...

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Oversight gap at private infusion clinics poses health risk, Ontario documents say

12 November 2018 - The lack of formal oversight at private clinics where medications are administered intravenously could pose risks ...

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