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  • Regulatory NewsRegulatory News

    Best of 2017: What Readers Clicked on This Year

    From Trump to biosimilars to a new digital health pilot run by the US Food and Drug Administration (FDA), here are the top 10 most-read articles of 2017, with some updates on what has occurred since the stories were published. 10. EMA to Suspend More Than 300 Drugs due to Unreliable CRO Studies Back in March, the European Medicines Agency (EMA) recommended the suspension of more than 300 approvals and applications for generic drugs for which bioequivalence studies w...
  • Regulatory NewsRegulatory News

    FDA Steps in to Regulate Microneedling Devices

    The US Food and Drug Administration (FDA) on Thursday issued a draft guidance detailing when it considers "microneedling" products to be medical devices and subject to regulation. In recent years microneedling has emerged as a trendy cosmetic procedure often advertised as a minimally invasive option for treating scars, wrinkles, acne and stretch marks, and is often performed at home or at plastic surgery centers. A quick Google search reveals product listings for mech...