Dunne Speaks on Drug Post-Approval Issues at Medical Device Law Conference

Shook, Hardy & Shook Philadelphia Partner Debra Dunne presents at the Introduction to Law and Regulation – Drug and Medical Device Conference on November 9-10 in San Francisco.  The event is sponsored by the Food and Drug Law Institute.

The conferences aims to give participants a comprehensive overview of the laws and Food and Drug Administration regulations affecting the drug and medical devices industries. 

Dunne’s breakout session covers post-approval issues specific to drug companies. She will explore examples of post-approval safety issues and discuss Annual Reports and Adverse Drug Experience Reports; post-approval label changes, Supplemental NDAs and ANDAs; and FDA post-approval safety communications. Other breakout sessions focus on biologics and biosimilars, clinical investigations, and the new drug approval process.