Cozen O’Connor: FDA Boot Camp 2016

FDA Boot Camp 2016


The Carlton Hotel

88 Madison Ave

New York, NY 10016

Date & Time

Start Date: 03/09/2016
End Date: 03/11/2016

Download Calendar Appointment


Ryan Blaney, a member of Cozen O’Connor's Health Care practice, will be speaking about “Drugs and Biologics: Labeling” at ACI's FDA Boot Camp.  

The labeling of the drug/biological product is the final stage of the approval process. The labeling affects what you can do post-approval. It is the point of transition between the approval process and post-approval world.

  • Labeling overview: key regulatory requirements, information, and contents
  • Review process for labeling
  • How does the final labeling control the scope of post-market activities?
  • How can and when should the labeling be amended post-market?
  • How is the labeling a defense in products litigation?
  • When can punitive damages may be rewarded with respect to labeling
  • Assessing the impact of labeling on reimbursement

The conference will consist of discussions on essential FDA regulatory law. FDA Boot Camp has been designed by leading regulatory attorneys to give professionals that work in conjunction with pharmaceutical, biologics and medical devise industries a strong working knowledge of core FDA competencies. 

For more information, click here.