In March 17 – 18 articles in Bloomberg BNA’s Health Care Daily Report and The Pink Sheet, life sciences partner Kellie Combs (Washington, D.C.) is quoted on the one-year delay concerning the effective date of the U.S. Food and Drug Administration (FDA’s) new intended use rule, which addresses the evidence the government can consider when determining whether a drug or medical device manufacturer can be held liable for off-label promotion.
In the March 17 – 18 articles Ms. Combs explained that FDA delayed the effective date in response to a citizen petition jointly filed by the Medical Information Working Group, the Pharmaceutical Research and Manufacturers of America, and the Biotechnology Innovation Organization. In the petition, the industry groups argued that FDA overstepped its authority and failed to follow proper procedures in issuing the rule.
Stay Up To Date with Ropes & Gray
Ropes & Gray attorneys provide timely analysis on legal developments, court decisions and changes in legislation and regulations.
Stay in the loop with all things Ropes & Gray, and find out more about our people, culture, initiatives and everything that’s happening.
We regularly notify our clients and contacts of significant legal developments, news, webinars and teleconferences that affect their industries.