This webinar took place on March 21, 2018.
Description: The FDA approval process for drugs and biologics is often lengthy and confusing, but it’s always high-stakes for applicants. In this webinar, former FDA Regulatory Counsel and current Womble Bond Dickinson attorney Daniel Orr presented key tips for securing FDA approval and solving problems with the Agency. The webinar was based on Dan’s experience representing FDA in scores of applications.
Agenda:
Orr covered the following topics:
- How to revive a stalled application or get an answer when FDA hasn’t responded;
- How to make the most of meetings with FDA and get the best advice from the Agency;
- When a citizen petition can help and what types of requests are likely to be granted;
- How to read between the lines of FDA guidance;
- How to make use of underutilized agency resources to speed approval;
- How to avoid inadvertent loss of reference product exclusivity for a biologic; and
- When to consult outside counsel.
Dan Orr is an FDA Regulatory partner in Washington, D.C. Before joining Womble Bond Dickinson, Dan 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.
Who Should Attend:
In-house counsel and regulatory affairs staff in the pharmaceutical and biologics sectors.
