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    • FDA Stays the Course on NanotechnologyFebruary 19th, 2009

      By Ricardo Carvajal— During a session at the Food and Drug Law Institute’s Second Annual Conference on Nanotechnology Law, Regulation, and Policy, senior FDA staff confirmed that the agency does not intend to issue regulations specific to products derived through nanotechnology, or to establish a definition …

    • DEA Proposes Placing of Tapentadol Into Schedule IIFebruary 18th, 2009

      By John A. Gilbert and Larry K. Houck – The Drug Enforcement Administration (“DEA”) has published a notice of proposed rulemaking to control Tapentadol as a schedule II substance under the Controlled Substances Act.  Schedules of Controlled Substances: Placement of Tapentadol Into Schedule II, 74 Fed. Reg. 7,386  …

    • ACCESS Act Reintroduced by Sen. Brownback; Previous Tiered Approval Nomenclature Scrapped and New Immunity Provision AddedJune 4th, 2008

      In late May, Senator Sam Brownback (R-KS) introduced S. 3046 – the “Access, Compassion, Care, and Ethics for Seriously Ill Patients Act” (the “ACCESS Act”).  The bill, which is similar to legislation Sen. Brownback introduced in the 109th Congress with the same title (i.e., S. …

    • FDA Law Blog Turns One! What a Year It Has Been! Thank You!March 6th, 2008

      One year ago today, Hyman, Phelps & McNamara, P.C., started FDA Law Blog with this post and a promise to provide you with timely updates on FDA enforcement actions, proposed rules, personnel changes, new and improved policies, along with related issues such as healthcare fraud …

    • And Now for Something Completely Different: OIG Issues Noteworthy Advisory Opinions Regarding Free Trial Program and Disease State Questionnaire KiosksFebruary 26th, 2008

      Advisory Opinion No. 08-04 (Free Trial Program) Last week, the Office of Inspector General (“OIG”) of the Department of Health and Human Services posted an advisory opinion addressing a free drug trial program for hemophilia A patients (“Proposed Arrangement”).  This was the first opinion outside of …

    • Ex-FDA Official Publishes White Paper on Navigating Quality System Regulations for Combination ProductsJune 26th, 2007

      In a recently published white paper (registration required), Steven Richter, a former FDA official and President and Chief Scientific Officer of Microtest Labs, discusses the regulatory challenges facing combination products.  The market for combination products is growing such that it is estimated to reach approximately …

    • Ill. District Court Recommends Reversal of HHS Federal Healthcare Program Exclusion DecisionMay 11th, 2007

      On April 30, 2007, the District Court for the Southern District of Illinois issued its opinion in Connell v. Secretary of Health and Human Servs., No. 05-cv-4122-JPG, 2007 WL 1266575 (S.D. Ill. Apr. 30, 2007) concerning a final decision by the Secretary of the Department …

    • FDA Law Blog LaunchMarch 6th, 2007

      Welcome to the FDA Law Blog, the blog of Hyman, Phelps & McNamara, P.C.  We’ll be covering topics of interest to FDA-regulated companies, fellow food and drug and healthcare lawyers and regulatory personnel, as well as people just generally interested in FDA law. First and foremost, …