By Michelle L. Butler – On June 12th, the final rule to amend FDA’s 1992 orphan drug regulations was published in the Federal Register. 78 Fed. Reg. 35117 (June 12, 2013). This final rule, which largely finalizes the revisions as proposed in October 2011, will …
By William T. Koustas – The Federal Trade Commission (“FTC”) has just released a revised guidance on its Red Flags Rule (“the Rule”) based on the amended Rule issued late last year in an effort to comply with the Red Flag Program Clarification Act of …
By Riëtte van Laack – On Friday, May 24, 2013, the California Assembly unanimously voted (72-0) for bill AB 227, amending Proposition 65 by including a new provision allowing certain small business owners 14 days to fix an alleged violation of Proposition 65’s warning requirements. AB …
By Kurt R. Karst – In a surprising turn of events, the Department of Justice (“DOJ”) sent a letter to Judge Edward R. Korman of the U.S. District Court for the Eastern District of New York indicating that FDA and HHS have complied with his …
By William T. Koustas & Jessica A. Ritsick – In light of California’s looming electronic pedigree requirement, still scheduled to become effective in 2015, we have been following Congress’s progress toward a national prescription drug track and trace system (see our previous post here). The …
By Joseph W. Cormier – FDA recently issued a draft guidance, titled “Contract Manufacturing Arrangements for Drugs: Quality Agreements” (“the Draft Guidance”), detailing its thoughts regarding appropriate quality agreements between product “owners”, which FDA defines as persons who introduce or cause the introduction of a …
Environmental seals and certifications have received renewed attention recently. The Federal Trade Commission (“FTC”), last week, submitted comments to a private group that is in the process of revising its certification program for “sustainable” seafood. The FTC did not take a stance on the program, …
By Jeffrey N. Gibbs, Jamie K. Wolszon & Jessica A. Ritsick – For many years, FDA has wrestled with how to regulate Laboratory-Developed Tests (“LDTs”). FDA Commissioner Margaret A. Hamburg is now renewing FDA’s call for more active FDA regulation of LDTs and touting the …
By Kurt R. Karst – Earlier this week, Momenta Pharmaceuticals, Inc. and Sandoz Inc. (“Petitioners”) filed their reply to the brief filed late last month by Amphastar Pharmaceuticals, Inc. (“Amphastar”) opposing Petitioners’ petition the U.S. Supreme Court to review the August 3, 2012 judgment of …
For years now, the American Conference Institute (“ACI”) has put on a series of excellent FDA-related conferences. Those of us in the Hatch-Waxman world look forward to attending the popular annual Paragraph IV Disputes, Maximizing Pharmaceutical Patent Life Cycles, and Hatch-Waxman Boot Camp conferences. They …
By Kurt R. Karst – Fumble!! For years now we have discussed and tracked various FDA decisions (or non-decisions as the case may be) on what have been referred to as “180-day exclusivity punts.” These are instances in which a first applicant eligible for 180-day …
By Jeffrey K. Shapiro – The Medical Device Amendments of 1976 (“MDA”), Pub. L. No. 94-295, 90 Stat. 539 (1976), are commonly described as the beginning of the modern era of device regulation. In one sense, this description is absolutely correct. The MDA established for …
By Ricardo Carvajal – DHHS and USDA announced the inaugural meeting of the 2015 Dietary Guidelines Advisory Committee (DGAC), scheduled for June 13-14. At the inaugural meeting, the DGAC will be provided with an orientation to the process for revising the Dietary Guidelines (revisions take place …
By JP Ellison – You may not recall our prior April 2009 blog post about the FTC’s settlement with Kellogg over its marketing campaign for Frosted Mini-Wheats. To briefly recap, Kellogg had claimed that “its cereal was “clinically shown to improve kids’ attentiveness by nearly …
By Kurt R. Karst – For the third time this year, FDA has been asked to recognize 5-year New Chemical Entity (“NCE”) exclusivity for a fixed-dose combination drug product containing both a never-before-approved active moiety and a previously approved active moiety. In a Citizen Petition …
