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  • 2019 Drug Safety Communications
    2019 Drug Safety Communications
  • Antimicrobial Resistance Information from FDA
    Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex and costly public health problem. Learn what FDA is doing to address AMR.
  • Biomarker Qualification Submissions
    The FDA CDER Biomarker Qualification Program invites submitters who have a biomarker qualification project accepted into the Program to voluntarily provide general information about their project and contact information to be posted on the FDA’s public web site. The table below lists submissions that are currently in the qualification process. Submissions listed here are only […]
  • Patient Engagement Collaborative
    The Patient Engagement Collaborative (PEC) is an advancement in FDA’s efforts to strengthen its relationship with patient communities and is being coordinated by the FDA’s Patient Affairs Staff (PAS) in the Office of Clinical Policy and Programs (OCPP).
  • All Guidances for Drugs
    All Guidances for Drugs