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 …
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Hyman Phelps McNamara
- The Device Submission eCopy RequirementsNovember 3rd, 2013
- Did FDA Shed Light on the Meaning of “Market Withdrawal” in the Updated RPM? Unfortunately, No.October 31st, 2013
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 …
- HHS Announces Its Interpretation that Exchange Plans Are Not “Federal Health Care Programs” For Purposes of Fraud and Abuse StatuteOctober 31st, 2013
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 …
- Game of Thrones: FDA is Once Again Petitioned on Biosimilar Naming; Novartis Wants Shared INNsOctober 31st, 2013
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 …
- FDA Lays Out Post-GDUFA Implementation Plans: A Brave New World or A Modern Utopia in the Making?October 30th, 2013
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 …
- Websites as Labeling for Foods ReduxOctober 30th, 2013
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 …
- FDA Makes Zohydro ER the First Approved Single-Entity Hydrocodone Analgesic, First ER/LA Opioid to Contain Hydrocodone, and First ER/LA Opioid With New LabelingOctober 29th, 2013
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 …
- FDA Prevails in Challenge to Generic ACETADOTE Approval; Court Grants Summary JudgmentOctober 28th, 2013
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 …
- DEA’s Delay Not Too Long, Not Too Short, but Just Right to Escape a Writ of Mandamus: Court of Appeals Denies Eisai Petition to Order Scheduling of FYCOMPAOctober 24th, 2013
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 …
- FDA Signals Issuance of Its Recommendation To DEA To Move Hydrocodone Combo Products to Schedule IIOctober 24th, 2013
By Delia A. Stubbs – While typically not made public, today, FDA issued a statement that it intends to forward a recommendation to DEA by December to move hydrocodone combination products from their current placement in Schedule III to Schedule II. That change would mean, among …
- GMA Presents Webinar on GRAS Self-DeterminationOctober 24th, 2013
The Grocery Manufacturers Association ("GMA") is presenting a webinar on GRAS self-determinations for food ingredients next Tuesday, October 29 from 1:30 to 3:00 p.m. EST. The webinar is intended to help food businesses understand applicable requirements and avoid missteps in ingredient safety assessments, and will …
- When is a Very, Very Long Delay the Same Thing as a Ban? FDA’s Review of Tobacco Product Submissions Under the MicroscopeOctober 23rd, 2013
By David B. Clissold – The United States Government Accountability Office (“GAO”) recently released a report examining FDA’s Center for Tobacco Products (“CTP”) entitled, “New Tobacco Products: FDA Needs to Set Time Frames for Its Review Process” (“GAO Report”). The report focused on CTP’s review of …
- At EFLA’s Third EU-US Food Law Conference, An Invigorating Discussion of International RecallsOctober 22nd, 2013
By Ricardo Carvajal – This past Monday, the European Food Law Association held its third conference on developments in food law in the EU and US. The conference was devoted entirely to the subject of food recalls and related public alerts, and the significant impact that …
- Jensen Farms Sues Auditor PrimusLabsOctober 21st, 2013
By Riëtte van Laack – Jensen Farms, (the Jensens), the growers facing criminal charges related to the deadly 2011 listeria outbreak linked to their cantaloupes, are suing Primus Group, Inc. d/b/a/ Primus Labs (Primus) alleging that the food safety consultants who audited the Jensens’ facilities shortly …
- FDA Largely Denies Citizen Petition on Single, Shared REMS System, But Outlines Agency Standards and ProcessesOctober 21st, 2013
By Kurt R. Karst – Now that the shutdown of the U.S. Federal Government is over and FDA’s Dockets Management Branch is open again, the backlog of docket submissions is rolling in on regulations.gov, including Citizen Petiton responses issued during the shutdown. One petition response …