The Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) within the US Food and drug Administration (FDA) published its annual “Report on the Sate of Pharmaceutical Quality” last week. The yearly report reviews the quality of drug products during the prior year, as measured by recall and product defect information, site inspections of manufacturers, and other post market data. The report provides a few insights that companies may want to consider when working with, or acquiring, contract manufacturers.  
Continue Reading Location Matters – Manufacturing Insights from FDA’s Annual Report on Drug Quality

On May 1, 2019, AAFCO provided updated guidelines regarding the use of hemp in animal food, including how this market is affected by the Agricultural Improvement Act of 2018 (the “Farm Bill”). Although the AAFCO is not a government agency, its members are government agencies that represent the 50 states, the US Food and Drug Administration (FDA) Center for Veterinary Medicine, and the Canadian Food Inspection Agency. 
Continue Reading AAFCO Issues Updated Guidelines Regarding Hemp in Animal Food

Norman E. (Ned) Sharpless, M.D., recently took the helm as Acting Commissioner of the US Food and Drug Administration (FDA). Dr. Sharpless most recently served as the director of the National Cancer Institute, part of the National Institutes of Health (NIH), which serves as the government’s principal agency for cancer research. Dr. Sharpless’s appointment comes on the heels of the resignation of former Commissioner Scott Gottlieb, M.D. on April 5, 2019.
Continue Reading FDA Update: Recent Trends and a New Regime

As computing power continues to become cheaper and more powerful, medical devices are increasingly capable of handling larger and larger sets of data. This provides the ability to log ever expanding amounts of information about medical device use and patient health. Whereas once the data that could be obtained from a therapeutic or diagnostic device would be limited to time and error codes, medical devices now have the potential to store personal patient health information. Interoperability between medical devices and electronic health record systems only increases the potential for medical devices to store personal information.
Continue Reading HIPAA/HITECH Compliance Strategies for Medical Device Manufacturers

On August 5, 2013, the U.S. Food and Drug Administration published a final rule on the labeling of foods as “gluten free.”[1] Gluten is a protein composite found in wheat, rye, barley, and their crossbred hybrids. Gluten gives elasticity to dough, helping it rise and keep its shape and often gives the final product a chewy texture. In order for a food to be labeled “Gluten Free” under the rule, the food may not contain 20 parts per million (ppm) or more gluten.[2] The rule applies to the claims “free of gluten” and “without gluten” as well.[3]
Continue Reading Will an FDA Rule Make People Sick? – FDA Establishes a Rule on the Labeling of “Gluten Free” Foods that Sets a Limit Above What Some Groups Claim Causes Adverse Reactions

On Thursday, June 13, 2013, the U.S. Food and Drug Administration (“FDA”) released a draft guidance on measures to help ensure the cybersecurity of medical devices. The draft guidance, titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” proposes cybersecurity features that should be incorporated into wireless, Internet- and network-connected medical devices (“cybersecurity-vulnerable devices”), as well as information that will be requested in premarket submissions for cybersecurity-vulnerable devices. In addition to the draft guidance, FDA also issued an FDA Safety Communication to medical device manufacturers, hospitals, medical device user facilities, health care IT and procurements staff, and biomedical engineers on cybersecurity for medical devices and hospital networks.
Continue Reading Cybersecurity: FDA Risks for Medical Devices

I am often called upon to address the nature of how regulatory controls may apply to the organization of healthcare companies in their ability to create, deliver, and capture value (their ‘business models’). While no summation could adequately capture all of the complexity inherent in this question, it would seem appropriate to briefly comment on some of the general recent trends I have seen, and how they may be shaped by various regulatory authorities.
Continue Reading Thoughts on Regulatory Constraints of Business Models

On March 25, 2012, the Supreme Court heard oral argument on the legality of “reverse payment” or “pay for delay” agreements between brand-name and generic drug manufacturers.

Reverse payment agreements settle patent infringement actions brought by a brand-name drug manufacturer against a potential generic competitor under the Hatch-Waxman Act. In contrast to typical settlements of patent infringement actions, it is the patent holder (the brand-name drug manufacturer) that agrees to pay a large sum of money to the accused infringer (the generic) in exchange for an agreement that the generic will not challenge the patent or enter the market for a period of time.Continue Reading Supreme Court Hears Arguments on “Pay for Delay” Agreements

The following blog article is drawn from the upcoming book Cloud Computing Deskbook, which is set to be released by Thomson Reuters West next summer. Cloud Computing Deskbook covers the legal and regulatory aspects of cloud computing, including those related to regulation by U.S. Food and Drug Administration. Please contact the author with any questions related to FDA regulation of cloud computing and software in general.

Cloud computing involves the delivery of computing as a service rather than a product. In a cloud computing solution, shared resources, software, and information are provided much like a utility, over a network to computers and other devices. Cloud computing has been embraced by the medical industry, and is used as a vital technology in electronic medical record systems and telemedicine solutions, among other products.Continue Reading The Impact of Cloud Computing on FDA’s Regulation of Medical Products