Requests that the FDA revoke its actions to approve the Abbreviate New Drug Application 216616, a generic version of Mifepristone, and modify the associated regimen (including the REMS) until the agency conducts the required consultation with the United States Fish and Wildlife Service (FWS) and National Marine Fisheries Service (NMFS) (collectively, “the Services”) as compelled by the ESA

2 organizations filed 2 public comments on Requests that the FDA revoke its actions to approve the Abbreviate New Drug Application 216616, a generic version of Mifepristone, and modify the associated regimen (including the REMS) until the agency conducts the required consultation with the United States Fish and Wildlife Service (FWS) and National Marine Fisheries Service (NMFS) (collectively, “the Services”) as compelled by the ESA, at the Food and Drug Administration.

Abstract

Open

Commenters (2)

• Center for Biological Diversity

  1 filing · confidence 97%
• Guttmacher Institutetrade assoc.

  1 filing · confidence 85%