• CDRH Seeks Participants for Staff Training ProgramMedical device companies and other stakeholders have until 30 April to apply to be a part of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) Experiential Learning Program (ELP), which is meant to help agency staffers better understand medical devices.
  • Duplicate MAAs: Amgen Wins EU-wide Approval for Two Humira BiosimilarsThe European Commission (EC) on Thursday granted two marketing authorizations for Amgen’s biosimilars to AbbVie’s blockbuster biologic Humira (adalimumab), known as Amgevita (adalimumab) and Solymbic (adalimumab).
  • EMA Calls to Suspend More Than 300 Drugs due to Unreliable Studies From Indian CROThe European Medicines Agency (EMA) on Friday announced it is recommending the suspension of more than 300 approvals and applications for generic drugs for which bioequivalence studies were conducted by Chennai, India-based contract research organization (CRO) Micro Therapeutic Research Labs.
  • Regulatory Recon: House Vote on Healthcare Bill Set for Friday Afternoon; Pfizer, German Merck mAb Gets First Approval for MCC (24 March 2017) 


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