Ensuring patient safety and drug manufacturing quality through partnership with European Union regulators

11 July 2019 - The Mutual Recognition Agreement with the European Union allows FDA to more effectively deploy our inspectional resources ...

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Statement on agency’s efforts to increase transparency in medical device reporting

21 June 2019 - In the spirit of promoting public transparency, the U.S. Food and Drug Administration’s Center for Devices ...

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Epilepsy medicine worry

24 June 2019 - A controversial change of epilepsy drug funding could see her and thousands of other people with ...

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Health advocate says FDA must walk a 'fine line' to ensure affordable drugs are safe

29 May 2019 - Public health advocate Dinesh Thakur said in an interview that aired Wednesday that the FDA is ...

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B.C. eye doctors warn province of spike in glaucoma cases linked to injections of eye drug

23 May 2019 - Thousands of retinal-disease patients in British Columbia are being exposed to an “increased risk of severe ...

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FDA's strengthened global inspection program helps ensure generic drug safety

17 May 2019 - Consumers must have confidence in the safety and quality of generic medicines.  ...

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Japan health ministry orders Ono Pharmaceutical to add warning to Opdivo cancer drug after death

10 May 2019 - The health ministry said Thursday that a patient taking the cancer drug Opdivo has died and ...

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Allegations of widespread fraud raise questions about the safety of generic drugs made overseas

10 May 2019 - It is something we've all heard before: generic drugs are the same as brand-name drugs. They ...

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Working together for safe medicines in the EU

6 May 2019 - EMA launches a social media campaign to highlight how the European medicines regulatory network keeps medicines ...

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When prescribing cures for 'overpriced' drugs, Government's first duty is do no harm

25 April 2019 - Overpriced. Excessive. Escalating. Gouging.  ...

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Use of multiple sclerosis medicine Lemtrada restricted while EMA review is ongoing

12 April 2019 - EMA has started a review of the multiple sclerosis medicine Lemtrada (alemtuzumab) following new reports of ...

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New EudraVigilance system improves reporting of side effects and detection of safety signals

27 March 2019 - The new and improved EudraVigilance, the European system for managing and analysing information on suspected adverse ...

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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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