BOSTON—Womble Bond Dickinson attorney Dan Orr will be among the presenters at the Food and Drug Law Institute’s Introduction to Drug, Biologics, and Biosimilars Law and Regulation course in Boston, MA, on July 23-24. Orr will speak on “Review and Approval of Abbreviated Applications and Biosimilar Products.”
Orr’s presentation will cover how FDA reviews applications for generic drugs and biosimilars and makes its approval decisions, as well regulatory exclusivity and patent issues that affect these products.
Other sections of the course include:
- Origins and Overview of the FDA,
- The FDA’s Regulatory Process;
- FDA Review and Approval of Drugs & Biologics;
- Post-Approval Issues;
- Regulation of Manufacturing; and
- Violations, Enforcement and International Issues.
Dan Orr is a Partner in the Washington, D.C. office of Womble Bond Dickinson. He advises clients concerning regulatory and patent issues in the pharmaceutical, biotech, and medical device sectors. Before joining WBD in January 2018, Orr was a Regulatory Counsel in FDA’s Center for Drug Evaluation & Research where he solved regulatory problems in a portfolio of drugs and biologics with combined annual sales of more than $37 billion.