By Kurt R. Karst – We were reminded earlier today that a new law has gone into effect in the state of Maine permiting the importation of drug products into the state from licensed retail pharmacies located in certain foreign countries. As we previously reported, …
By Jay W. Cormier – Notwithstanding the government shutdown, on Tuesday, October 1st, FDA’s Center for Devices and Radiological Health (“CDRH”) issued a final guidance regarding filing for an investigational device exemption (“IDE”) for medical device early feasibility studies. At the heart of the guidance is that …
By Kurt R. Karst – We’re now entering the second week of the shutdown of the federal government (or “the lapse period” as some have called it), and there does not appear to be an end in sight. In fact, the environment in Washington, D.C. has …
By Jeffrey K. Shapiro – There has been a lot of talk about hostage taking during the recent federal government budget impasse. But Congress is not the only one taking hostages in Washington. The recent draft Medical Device Reporting (MDR) guidance reminds us (pp. 4-5) …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Kermit L. Jones, J.D., M.D. has joined the firm as an Associate. Prior to joining the firm, Dr. Jones served as a 2012-2013 White House Fellow assigned to the Secretary of Health and Human Services, …
By Riëtte van Laack & Ricardo Carvajal – On September 19, 2013, Cargill entered into a $5 million settlement agreement to dispose of a class action lawsuit regarding its advertising for Truvia® products as “natural.” Plaintiffs charged that the products are not natural because they …
By Jay Cormier & Alan Kirschenbaum – The Patient Protection and Affordable Care Act made extensive changes to the 340B drug discount program, which we have previously described. Among other things, the statute expanded the categories of covered entities entitled to purchase drugs at the …
By John R. Fleder – On September 26, 2013, the United States Attorney for the District of Colorado announced that he had filed a six count criminal Information against Eric and Ryan Jensen. The government alleges that the defendants violated the FDC Act by introducing adulterated …
By Kurt R. Karst – It was not a question of whether, but when FDA would issue its first Warning Letter to a facility covered by the Generic Drug User Fee Amendments of 2012 (“GDUFA”) that failed to self-identify its facility and pay applicable user fees. …
By Ricardo Carvajal & Kurt R. Karst – According to contingency plans drawn up by the Department of Health and Human Services, 45% of FDA’s nearly 15,000 staff were to be furloughed in the absence of enacted annual appropriations – popularly referred to as a …
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 …
