The New York Academy of Sciences will present a conference on scientific and regulatory issues pertaining to nanomedicine on November 21. The conference will feature speakers from the U.S. and abroad so as to provide domestic and international perspectives. Hyman, Phelps & McNamara’s Ricardo Carvajal …
By Kurt R. Karst – Earlier this week, sanofi-aventis U.S., LLC (“Sanofi”) filed a Complaint in the U.S. District Court for the District of Columbia against FDA in what appears to be a first-of-its-kind lawsuit. Sanofi alleges that FDA’s decision to make public a copy of …
By Ricardo Carvajal – Colorado’s Department of Revenue recently published retail marijuana rules to implement that state’s Retail Marijuana Code (“RMC”). C.R.S. 12-43.4-101 et seq. The rules took effect on October 15, and are the culmination of a change in Colorado law that began with an …
By Jennifer M. Thomas – I have monitored the drug shortage issue over the last few years with professional interest and general concern (see here). However, the situation was recently brought home to me when I took my four-month old in for her second round of …
Postponed due to the partial government shutdown, this conference will address numerous compliance and enforcement issues of interest to dietary supplement manufacturers and distributors, and will feature discussion of the anticipated impacts of FSMA implementation. Senior FDA and state officials will provide their perspectives, …
By Karla L. Palmer – On Monday, November 4, 2013, the Drug Enforcement Administration (“DEA”) published a notice of proposed rulemaking (“NPR” ), proposing to place the substance 2 –((diemthylamino)methyl)-1-(3-methyloxyphenyl) cyclohexanol), and its salts, isomers, salts of isomers, and all isometric configurations of possible forms, …
By Allyson B. Mullen – Now that the eCopy program is well underway, it might be a good idea to review how the program works and consider a few of the common pitfalls. Although nearly a year has passed since the final guidance document for the …
By Jessica A. Ritsick, Jay W. Cormier & John R. Fleder – If you have ever needed to determine whether pulling an FDA-regulated product from retail shelves is a “market withdrawal” or a “recall” you know that the line between these two terms at times is murky …
By Delia A. Stubbs & Alan M. Kirschenbaum – Yesterday, in a letter to Representative Jim McDermott, Secretary of Health and Human Services (“HHS”) Kathleen Sebelius stated that qualified health plans (“QHPs”) and other programs related to health insurance exchanges under Title I of the …
By Kurt R. Karst – The forces backing implementation of an FDA policy under which biosimilar biological products, licensed under Section 351(k) of the Public Health Service Act (“PHS Act”) as added by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), and their …
By Kurt R. Karst – The Generic Pharmaceutical Association (“GPhA”) held its annual Fall Technical Conference this week. There were lots of interesting topics on the conference agenda, such as complex drugs, ANDA filing and refuse-to-receive issues (see the recent FDA guidance here), adverse event …
By Ricardo Carvajal – We previously reported on a case – Wilson v. Frito-Lay North America, Inc. – in which a federal district court held that statements on a food company’s website do not constitute labeling even though the labels of some products include a reference …
By Delia A. Stubbs – The amount of government activity on issues involving controlled substances last week makes the furlough seem like a figment of our imagination. Following issuance of a press release on hydrocodone rescheduling and a court ruling on DEA’s delay on the scheduling …
By Kurt R. Karst – In a decision handed down on September 30, 2013 (but not unsealed until last Friday), the U.S. District Court for the District of Columbia rebuffed a challenge by Cumberland Pharmaceuticals Inc. (“Cumberland”) to FDA’s approval of a generic version of Cumberland’s acetaminophen …
By Delia A. Stubbs – Earlier this week, the U.S. Court of Appeals for the D.C. Circuit denied Eisai, Inc.’s (“Eisai’s”) petition to order DEA – in essence – to get moving on the scheduling of its drug, FYCOMPA (perampanel), which FDA approved in October 2012 …
