By William T. Koustas & Jessica A. Ritsick – With California’s electronic pedigree requirement set to take effect in 2015, we have been following recent efforts by Congress to enact a national prescription drug track and trace system (see our previous posts here, here, here, …
By William T. Koustas – We have previously reported (here and here for example) on the litigation between Regenerative Sciences, LLC (“Regenerative”) and FDA. Regenerative is a Colorado company that owns a medical procedure known as the Regenexx Procedure. It is a non-surgical procedure by …
By Jeffrey K. Shapiro – As everybody has noticed, FDA finalized its guidance on Mobile Medical Applications earlier this week. We blogged on the draft version here. The final guidance is similar to the draft guidance – but with improved clarity. Hence, it has expanded from …
By Allyson B. Mullen – Have you ever heard of an “Immediately in Effect (IIE)” guidance document? Thanks to a new draft SOP issued by CDRH, you may soon see this new species of guidance on a regular basis. In section 405 of Food and Drug …
By Kurt R. Karst – Anyone from the United States who has visited a foreign city – like São Paulo, Brazil or Mumbai, India – knows immediately upon exiting the sealed environment of their aircraft that they are no longer in the United States. There’s …
By Jeffrey N. Wasserstein & Alexander J. Varond – Last week, ahead of the September 23, 2013 compliance deadline for its HITECH final rule (also referred to as the “Omnibus Final Rule”), the Department of Health and Human Services issued guidance entitled “The HIPAA Privacy …
By Kurt R. Karst – FDA’s latest Report to Congress, required by FDC Act § 505(q)(3), on the Agency’s experience with so-called “505(q) citizen petitions” during Fiscal Year 2012 (“FY2012”) is largely a rehash of the FY2011 Report to Congress (see our previous post here on …
By Jennifer D. Newberger – At long last, it is here: FDA has issued the final rule implementing the unique device identifier (UDI) requirements, originally required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and then again by the Food and Drug …
By Ricardo Carvajal – Rep. Frank Pallone (D-NJ) introduced legislation – H.R. 3147, the Food Labeling Modernization Act of 2013 – that would grant FDA significant new authorities in the area of food labeling. In what is identified as the bill’s “signature initiative,” FDA would be directed to establish …
By David B. Clissold – Last week, House Democrats and a consortium of public health organizations turned up the heat on FDA to issue “deeming” regulations that would bring electronic cigarettes and other types of tobacco products under the Agency’s jurisdiction. The Family Smoking Prevention and …
By Kurt R. Karst – The titles – and sometimes even the content – of some of our posts are inspired by the things we experience (or have experienced) in our regular, non-attorney lives. For years now we’ve weaved together with food and drug law …
By Wes Siegner & Paul M. Hyman – The term “medical food” was first defined by statute in the Orphan Drug Act Amendments of 1988. The medical food category is closely related to the already existing category of “foods for special dietary use,” authorized by …
By Riëtte van Laack – As previously reported here, in July, the American Meat Institute and several international meat industry organizations filed a lawsuit in an effort to stop the Agricultural Marketing Service ("AMS") of the USDA from implementing the Country of Origin Labeling ("COOL") rule, …
By Etan J. Yeshua – Three months after announcing a strategic research plan to support its regulatory agenda, FDA's Center for Food Safety and Applied Nutrition ("CFSAN") this week announced its regulatory priorities for 2013 and 2014, giving those in the food, dietary supplement, and cosmetic …
By Delia A. Stubbs – As previously reported, the Physicians for Responsible Opioid Prescribing (“PROP”) filed a Citizen Petition in March requesting that FDA limit the labeling of “controlled release” opioids to severe-only pain in non-cancer patients. The petition also requested that FDA impose certain …
