Where’s the love? Apparently, not at the FDA. On September 22 the FDA issued Warning Letter CMS# 532236 to Nashoba Brook Bakery, of Concord, Mass. Among several infractions cited in the letter was one for the misbranding of granola bars—misbranding that must be corrected within 15 days to avoid …
It’s Not Always Obvious What’s Obvious
August 31, 2017 Leave a Comment
If you think it’s easy to determine what’s obvious and what’s not, take a look at the recent Federal Circuit decision in Millennium Pharmaceuticals v. Sandoz. The lower court had determined that a process was obvious. The circuit court held that it was not obvious and that the lower court’s determination …
Solution to One Problem Brings Two More
August 14, 2017 Leave a Comment
An August 2 FDA warning letter provides a reminder that solving one problem can create a new problem—or more. The letter to Coleman Peanut Co., in Petersburg VA, recites that the company uses a cat “as the firm’s pest control.” Presumably, the cat is effective because the letter contains no mention of …
PhRMA and BIO Take Off-Label Communication Into Their Own Hands with New Guidelines
July 29, 2016 Leave a Comment
Industry for years has sought clarity on off-label communications. Numerous meetings on the topic have taken place between the U.S. Food and Drug Administration (FDA) and industry, citizen petitions have been filed, legislation has been introduced in Congress and a series of legal cases have been brought, …
Federal Trade Commission Releases New Mobile Health Apps Interactive Tool
April 19, 2016 Leave a Comment
The Federal Trade Commission (FTC) in conjunction with the Office for Civil Rights (OCR), the HHS Office of National Coordinator for Health Information Technology, and the Food and Drug Administration, have developed a new web-based interactive tool to assist developers of health-related mobile apps identify …
Federal Rx for Opioid Epidemic: Tighten Rules on Prescribers
March 29, 2016 Leave a Comment
The federal government has made no secret of its concern over what is invariably described as an “opioid epidemic” sweeping the country. Nor is it a secret that the government sees prescribing physicians—especially primary care physicians—as the best choke point for slowing the flow of …