Drugs and Biological Product Provisions – From Patient Input and Expanded Access Programs to Limited-Population Approval and Medical Countermeasures
As a service to our clients and friends, Covington will present a series of complimentary webinars on the 21st Century Cures Act, signed into law today by President Barack Obama. Our presenters will include Wade Ackerman, the former Senior FDA Counsel to the Senate HELP Committee, who negotiated many of the FDA-related provisions included in the legislation; Krista Carver, who worked intensively on behalf of industry as Congress considered the new law; and Denise Esposito, who joined Covington in 2015 after serving as a senior FDA official from 2010 to 2015.
The 21st Century Cures Act will affect the regulation of medical products across life sciences sectors and includes changes to FDA’s authorities typically seen in recent years only during drug and device user fee reauthorizations. Our panels will examine key provisions of the Act, analyze their impact on the regulation of medical products, and provide practical tips to consider as the new law is implemented by the Trump Administration.