Media Mention

Sonali Gunawardhana Previews Upcoming AdvaMed Panel on the Department of Justice’s Focus on Safety and FDA cGMP Enforcement

Med Device Online
September 24, 2014

Sonali P. Gunawardhana, an attorney in Wiley Rein’s Food & Drug Law Practice, talked with Med Device Online about a panel she will chair next month regarding enforcement repercussions for manufacturers who fail to comply with the U.S. Food and Drug Administration’s (FDA) Current Good Manufacturing Practices (cGMP).  The October 7 legal track panel discussion, part of the AdvaMed 2014 conference in Chicago, will focus on steps medical device makers can take to avoid the types of compliance failures that have led to civil and criminal fines for some pharmaceutical companies.

Ms. Gunawardhana’s panel also will feature Ralph J. Caccia, a partner in Wiley Rein’s White Collar Defense & Government Investigations Practice.

“The message of this panel is, ‘Hey, medical device community, don’t be asleep at the wheel,’” Ms. Gunawardhana—who previously served as regulatory counsel at the FDA—said in yesterday’s article.  “You should be learning from the mistakes of your pharmaceutical brethren.  Similar issues can occur in the medical device world, and you should be prepared to address these issues so as to avoid such costly penalties for cGMP noncompliance.”

Click here to read the full article.

Read Time: 1 min

Related Professionals

Contact

Maria Woehr Aronson
Director of Communications
202.719.3132
maronson@wiley.law 

Molly Peterson
Senior Communications Manager
202.719.3109
mmpeterson@wiley.law

Jump to top of page

Necessary Cookies

Necessary cookies enable core functionality such as security, network management, and accessibility. You may disable these by changing your browser settings, but this may affect how the website functions.

Analytical Cookies

Analytical cookies help us improve our website by collecting and reporting information on its usage. We access and process information from these cookies at an aggregate level.