Emerging Issues in FDA Inspections and Oversight
As the COVID pandemic has subsided, FDA has resumed its domestic and foreign inspection program. The agency is not only visiting firms in the U.S. and abroad, but using new tools and focusing on some new areas. Please join Howard Sklamberg and Abeba Habtemariam, partners at Arnold & Porter, in a discussion of these new trends and how firms can prepare for FDA's new inspection focus.
Howard and Abeba will discuss both pharmaceutical and medical device inspection trends. Specific topics:
- FDA's use of remote regulatory assessments both in pre-approval and pre-license inspections and post-market, the role of mutual recognition agreements, and quality maturity management
- FDA's areas of emphasis in drugs, including supply chain oversight and cell and gene therapy manufacturing
- Areas of emphasis for device inspections, including for software-based devices
- FDA enforcement priorities
This is the first in a two-part series. The second webinar will cover developments in Europe on November 8.