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    • DEA Federally Controls Carisoprodol as a Schedule IV Substance, Establishes Regulatory TimelineDecember 12th, 2011

      By Larry K. Houck – The Drug Enforcement Administration (“DEA”) published its long awaited final rule in the Federal Register today (76 Fed. Reg. 77,330 (Dec. 12, 2011)) placing carisoprodol into schedule IV of the federal Controlled Substances Act (“CSA”).  Federal scheduling of carisoprodol follows control …

    • Pending DESI Program Proceedings – The ListDecember 11th, 2011

      By Kurt R. Karst –       For years we’ve heard rumors of a relatively current list, compiled by FDA, of proceedings pending under the Drug Efficacy Study Implementation (“DESI”) program.  At one time, in the early 1980s, the list was included as an addendum to the Orange …

    • FSIS Proposes to Further Expand the Types of Labels that Do Not Require Pre-Market ApprovalDecember 8th, 2011

      By Riëtte van Laack – On December 5, 2011, the Food Safety Inspection Service (“FSIS”) of the USDA proposed to amend its regulations concerning label approval of meat and poultry products.  The proposed rule would further expand the types of labels that do not require pre-market …

    • HP&M Files Comments on Draft NDI Guidance; Request Withdrawal and Reissuance Reflecting DSHEA IntentDecember 7th, 2011

      On December 2, 2011, Hyman, Phelps, & McNamara filed comments (here and here) to the controversial draft guidance on New Dietary Ingredient (“NDI”) notifications that FDA issued in July 2011.  We have a keen interest in the draft guidance and have previously posted on it …

    • FDA Proposes Generic Drug User Fee System and Performance GoalsDecember 7th, 2011

      By Kurt R. Karst –       Just one day after FDA announced a December 16th public meeting and comment period to discuss the Agency’s proposed recommendations for a user fee program for biosimilar biological products for Fiscal Years (“FYs”) 2013 through 2017 (see our post here), the …

    • Job Opportunity: HP&M Seeks Attorney with Significant Medical Device ExperienceDecember 7th, 2011

      Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks a mid-level to senior associate or counsel with substantial experience in medical device law and regulation to assist with a growing practice.  Strong writing skills are required.  Compensation is …

    • Senator Brown Proposes Modifications to the De Novo ProcessDecember 6th, 2011

      By Jennifer D. Newberger – On December 5, 2011, Senator Scott Brown (R-MA) introduced S. 1943, the “Novel Device Regulatory Relief Act of 2011.”  The bill is intended to amend section 513 of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to expedite the process …

    • FDA Proposes Biosimilar and Interchangeable Biological Product User Fee System and Performance GoalsDecember 6th, 2011

      By Kurt R. Karst –       On December 7, 2011, FDA will publish a Federal Register notice – a prepublication version of which is available here – announcing a December 16th public meeting and comment period (Docket No. FDA-2011-N-0326) to discuss the Agency’s proposed recommendations for a …

    • Dietary Supplement GMPs: Repeat Offenders BewareDecember 5th, 2011

      By Ricardo Carvajal -  Recent FDA actions suggest that dietary supplement firms who fail to correct deficiencies in their GMP’s do so at their peril.  For example, FDA recently filed a complaint for permanent injunction against ATF Fitness Products, Inc. et al. ("ATF"), a manufacturer and …

    • Representative Slaughter Criticizes FDA’s Inaction Concerning the Use of Antibiotics in Animal AgricultureDecember 4th, 2011

      By Riëtte van Laack – Representative Louise Slaughter (D-NY) recently sent a 4-page letter to FDA expressing her discontent with the Agency’s action (or lack thereof) related to antibiotic use in animal agriculture.  Specifically, Rep. Slaughter criticizes: 1. FDA’s delay in finalizing the industry guidance #209, titled the …

    • When “All Natural” Isn’tDecember 1st, 2011

      By Ricardo Carvajal – FDA issued a warning letter to a food manufacturer for labeling as “all natural” a product that contains disodium dihydrogen pyrophosphate, purportedly a synthetic chemical preservative.  The letter cites an alleged violation of FDC Act § 403(a)(1), under which a food is …

    • FDA Law Blog Honored by LexisNexisDecember 1st, 2011

      FDA Law Blog is pleased to announce that we’ve been selected as one of the LexisNexis Top 25 Torts Law Blogs of 2011!  Here’s what the folks at LexisNexis had to say: The Top 25 group includes some of the best talent in the blogosphere and …