Лента новостей - FDA.GOV

  • FY 2019 Generic Drug Regulatory Science Initiatives Public Workshop - 05/01/2019 - 05/01/2019
    FDA will hold a public workshop that will provide an overview of the current status of the regulatory science initiatives for generic drugs and will provide an opportunity for public input on research priorities in these topic areas. FDA is seeking input from a variety of stakeholders––industry, academia, patient advocates, professional societies,
  • Section 503A Bulks List Final Rule Questions and Answers; Small Entity Compliance Guide;
    Section 503A Bulks List Final Rule Questions and Answers; Small Entity Compliance Guide;
  • What's New Related to Drugs
    Want to know what's new? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.
  • Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule
    Blissful Remedies., is voluntarily
    recalling only Lot No.: 112710 with expiration 03/2019 found embedded on the top of package of
    kratom ( mitragyn a speciosa) powder products, it manufactured, processed, packed, and/or held,
    between “March 1, 2018” to “April 30, 2018” to the consumer level. The products have been found by
    the U.S. Food and Drug Administration (“FDA”) via sample testing to have salmonella contamination.
    Blissful Remedies has not received reports of adverse events related to this recall. In lieu of such
    FDA findings the company has implemented standard operating procedures and sterilization
    processes in accordance to FDA guidelines.
  • FDA approves ruxolitinib for acute graft-versus-host disease
    On May 24, 2019, the Food and Drug Administration approved ruxolitinib (JAKAFI®, Incyte Corporation) for steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older.

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