• US FDA norms for clinical investigators, sponsors & to ascertain need for human studies for IND
  "In a major development on the regulatory landscape for clinical trials, the US Food and Drug Administration (FDA) has now issued a guidance which is intended to assist clinical investigators, sponsors, sponsor-investigators and institutional review boards (IRBs)."
  in Public bookmarks with clinical organization research services trial trials
• US FDA seeks industrys comments on new draft norms on ANDA submissions
  The US FDA has sought the pharma industry's comments on its draft guidelines on ANDA (abbreviated new drug application) submissions ― Refuse-to-Receive Standards.
  in Public bookmarks with clinical organization research services trial trials
• US FDA to reduce backlog of generic drug applications, increase inspections
  With US Food and Drug Administration (FDA) planning to work towards reducing the backlog of generic drug applications under the Generic Drug User Fee Act (GDUFA), Indian pharmaceutical companies have however cited challenges like approval time for abbreviated new drug applications (ANDAs)– the applications filed for generic drugs and heightened inspection activities, as GDUFA requires stepping up number of foreign inspections.
  in Public bookmarks with clinical organization research services trial trials

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