Reacting to a February 2007 FDA safety alert on the off-label use of erythropoietic stimulating agents (ESAs), Noridian Administrative Services (Noridian), a Medicare Administrative Contractor for 13 states in the west and midwest, announced that, effective March 5, 2007, Medicare will deny payment for the …
In a case that may have wider implications for the data on which FDA bases its decisions, a medical marijuana rights group, Americans for Safe Access (ASA), has sued HHS and FDA for violating the requirements under the Data Quality Act, 44 U.S.C. § 3516 …
On March 1, 2007, the District of Columbia Circuit Court of Appeals heard an oral argument in Abigail Alliance v. von Eschenbach. Previously, a divided court of appeals had ruled that where there are no other FDA-approved treatment options, a terminally ill patient’s access to …
FDA’s highly anticipated PDUFA IV proposal, if enacted by Congress, would eliminate any possibility that a 505(b)(2) application might not be an application subject to PDUFA user fees. Among various technical changes included in the Agency’s PDUFA IV proposal, FDA recommends that Congress “[s]implify the …
In July 2004, the Coalition for Mercury-Free Drugs (the Coalition) filed a citizen petition with FDA requesting that the agency prohibit the use of thimerosal and other mercury compounds in vaccines and drugs. In August 2006, the Coalition went to court claiming that FDA had …
In Late February 2007, FDA announced in the Federal Register the withdrawal of approval of 128 suitability petitions in accordance with the Pediatric Research Equity Act of 2003 (“PREA”). FDA’s notice states: [T]hese approval decisions are being withdrawn because ANDAs were never submitted and PREA requires …
On February 27, FDA announced a draft guidance, titled Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration (CAM Guidance). The CAM Guidance was prepared by the Office of Policy and Planning within FDA’s Office of …
On March 1, 2007, FDA announced that it issued 20 Warning Letters to companies marketing and distributing unapproved drug products containing ergotamine tartrate, a drug used to treat vascular headaches, including migraines. According to FDA’s press release announcing the enforcement action: In addition to marketing …
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, …
