…diversion of an investigational drug that is subject to the Controlled Substances Act pursuant to 21 C.F.R. 312.69.  Failing to store a Schedule II controlled substance in a securely locked…

…on the matter.  In December 2010, a group of purchasers, including Louisiana Wholesale Drug Company, Inc. and Arthur’s Drug Store, Inc., asked the Supreme Court to address whether a patent…

…marketing materials into “menus.” And FDA purports to provide flexibility by allowing restaurants to declare calories via in-store tablets and electronic kiosks; but this is nothing new and is hardly…

…courier to the patient’s home and not via a retail store.  FDA has indicated that it intends to approve REMS for Actiq and Fentora (both already approved fentanyl products) in the…

…mobile app, the uChek Urine Analyzer.  The app can be downloaded for 99 cents through the iTunes Apps Store, and uses the phone’s camera to read urine dipsticks.  The app…

…Express (or “OB Express” as it comes up in the Apple App Store).  (We understand that the app was slated for release on Friday, October 30, 2015, but a couple…

…store for some controversy in the not too distant future.  FDA published a draft version of the guidance in February 2014 (see our previous post here) saying that the Agency…

…store in honeycombs.” According to FDA, this definition accurately reflects the common usage of the term honey.  In the absence of a federal standard of identity, a number of states…

…reinforces existing laws and regulations to the industry. FDA broadly defines honey as “a thick, sweet, syrupy substance that bees make as food from the nectar of flowers and store…

…broad types: Mobile apps that connect to medical devices to control them or to display, store, analyze or transmit patient specific medical device data. Mobile apps that transform a mobile…

…the education program.  The patient education materials must include, among other things, a Medication Guide and information on how to properly take an opioid, report adverse effects, and store opioids. …

…a new and exciting branch of health science.  Where FMT will fit in is not yet clear.  One can imagine a day when patients routinely store autologous fecal samples as…

…they reach store shelves – meaning that every day, millions of Americans are ingesting substances whose safety and efficacy are not guaranteed.”  In the video message, she discusses products that…

…while schedule III-V substances may be stored in a less secure controlled substance cage or other enclosure. As to controlled substance manufacturers and distributors of hydrocodone products,  unlike the prior…

…store, analyze, and/or keep track of his or her medical data values. Draft Mobile Medical App. Guidance at 14. In short, if an app is intended to maintain and establish…