Drugs and Biologics Labeling: Appreciating the Importance of the Final Step of the Approval Process

September 14, 2022 4:45pm

Torrey Cope
Partner
Sidley Austin LLP (Washington, DC)

Michael Hinckle
Partner
KL Gates LLP (Washington, D.C.)

The labeling of the drug/biologic is the final stage of the approval process. The label controls what you can do post-approval and as such it is the point of transition between the approval process and post-approval world.

  • Labeling overview: key regulatory requirements, information, and contents
  • Exploring the review process for labeling
  • Incorporating clinical trial data on the label
  • Appreciating the influence of final labeling on the scope of post-market activities
  • Amending labeling post-market
  • Using labeling as a defense in products liability litigation
  • Exploring label carve outs
  • Discussing the requirements for skinny and narrow labeling