By Ricardo Carvajal – The Federal Trade Commission ("FTC") issued the latest in a series of reports on sales, advertising, and promotion of cigarettes and smokeless tobacco. The reports are based on data submitted to FTC by industry. The cigarette report states that the “total number …
The Institute of Food Technologists (“IFT”) is requesting proposals for its March 28-29, 2012 annual Wellness Conference, which will explore new trends and examine recent scientific, technological, and business information in the health and wellness sector of the food industry. The conference will cover a …
By Cassandra A. Soltis & Anne Marie Murphy – The Department of Health and Human Services, Office of the Secretary, along with the Office of Science and Technology Policy, has issued an advance notice of proposed rulemaking (“ANPRM”) requesting comments on how to update current regulations on …
By Ricardo Carvajal – FDA announced fee rates for reinspections of domestic and foreign facilities, importer reinspections, and noncompliance with a recall order – all authorized by the Food Safety Modernization Act ("FSMA"). The fees kick in on October 1, 2011. The hourly fee rate is …
By Kurt R. Karst – Each year around this time, some of us at our firm participate in a version of The Price Is Right Showcase Showdown in which folks “bid” on what they think the PDUFA application user fee rate will be set at for …
By Jennifer D. Newberger – On July 29, 2011, the Institute of Medicine ("IOM") released its long-awaited report, “Medical Devices and the Public’s Health, The FDA 510(k) Clearance Process at 35 Years.” Both industry and FDA were likely surprised by the IOM’s recommendation: do away with the …
By Ricardo Carvajal – A federal district court dismissed with prejudice a claim that Bayer’s labeling of gummy vitamins violated the Arkansas Deceptive Trade Practices Act. Plaintiff alleged that the brand name “ONE A DAY” is misleading because the daily serving size for the vitamins is …
By Susan J. Matthees – FDA recently denied a 2006 citizen petition submitted by Wyeth Consumer Healthcare (“Wyeth”) requesting that FDA withdraw a 2005 Notice of Proposed Rulemaking (“NPRM”) that would reclassify phenylpropanolamine (“PPA”) from Category I (generally recognized as safe and effective) to Category II (not …
On July 26, 2011, Hyman, Phelps & McNamara, P.C. filed a request for a one-year comment period to allow affected businesses adequate time to respond to a lengthy and controversial draft guidance on New Dietary Ingredient ("NDI") notifications that FDA issued earlier this month. Our …
By Jennifer D. Newberger – On July 27, 2011, the Center for Devices and Radiological Health ("CDRH") announced the issuance of a Draft Guidance titled “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device.” When finalized, this guidance document will …
By Kurt R. Karst – Late last week, the U.S. District Court for the Eastern District of Virginia granted the U.S. Patent and Trademark Office’s (“PTO’s”) Motion for Summary Judgment in a challenge mounted by the Genetics & IVF Institute (“GIVF”) to the PTO’s August 2010 …
By Carmelina G. Allis – The FDA’s “Draft Guidance on Mobile Medical Applications” is applicable to software products (or “mobile apps”) intended for use on mobile platforms that are handheld in nature, such as, for example, the iPhone® and Android® phones. “Mobile medical apps” are defined …
By Kurt R. Karst – FDA has been asked for a fourth time to provide an advisory opinion on compliance with the Hatch-Waxman Orange Book patent listing requirements for a patent that claims a drug delivery device integral to the administration of the active ingredient, but …
By Kurt R. Karst – Suppose FDA approves a New Drug Application (“NDA”) – NDA No. 1 – and grants a period of 5-year New Chemical Entity (“NCE”) exclusivity, but there are no patents listed in FDA’s Orange Book for the NDA, and therefore, there is …
By Ricardo Carvajal – The integration of federal and state food safety systems is one of the goals of the Food Safety Modernization Act. To that end, FDA recently announced the availability of grant funding to help with the “design, development, delivery, and maintenance of a …
