Media Mentions
2008
Arnold Friede, Robert Nicholas and Paul Radensky’s article "FDA and Drug Advertising: No Attention Deficit On Nooed For 'Substantial Evidence'" appeared in the November 7 issue of the Washington Legal Foundations' Legal Backgrounder.
Arnold I. Friede, Robert B. Nicholas, Paul W. Radensky M.D., Health, Life Sciences & Medical Devices, Life Sciences - FDA, Life Sciences - Health
Arnold Friede was mentioned in the October 6 issue of the Pink Sheet in an article regarding the McDermott White Paper entitled "FDA Challenges Implied Outcomes Claims for Several ADHD Products: An Analysis." "Beyond extending FDA's enforcement reach into new media, the ADHD letters may be establishing a new enforcement standard across all types of communication," Mr. Friede said.
Arnold I. Friede, Robert B. Nicholas, Paul W. Radensky M.D., Health, Life Sciences & Medical Devices, Life Sciences - FDA, Life Sciences - Health
McDermott Will & Emery's White Paper entitled "FDA Challenges Implied Outcomes Claims for Several ADHD Products: An Analysis" was featured in the Guest Column on October 3 in Health Law360.
Arnold I. Friede, Robert B. Nicholas, Paul W. Radensky M.D., Health, Life Sciences & Medical Devices, Life Sciences - FDA, Life Sciences - Health
McDermott was mentioned in the October 2 issue of FDA's Webview in an article regarding the Firm's On the Subject discussing the letters issued by the U.S. Food and Drug Administration's (FDA) Division of Drug Marketing, Advertising, and Communications alleging that promotional material for certain products intended for use in treating attention deficit hyperactivity disorder (ADHD) made implied claims about an effect on ADHD "outcomes" that were not supported by "substantial evidence." FDA Webview notes, "Attorneys at McDermott...say FDA's Warning Letters and notices of violation to several manufacturers of ADHD drugs mean that drug companies wanting to avoid a challenge from CDER's Division of Drug Marketing, Advertising, and Communications (DDMAC) should review ad and promotional materials in all therapeutic categories to determine whether they make implied outcomes claims of the kind alleged by DDMAC in the ADHD letters."
Arnold I. Friede, Robert B. Nicholas, Paul W. Radensky M.D., Conflicts of Interest - Health, Health, Life Sciences & Medical Devices, Life Sciences - FDA, Life Sciences - Health
McDermott Will & Emery was mentioned in the July 2008 issue of DTC Insights – DTC Forecast in an article summarizing McDermott's recent White Paper on Merck settling the Vioxx Litigation with State Attorneys General.
Arnold I. Friede, Elizabeth I. Hack, Robert B. Nicholas, Paul W. Radensky M.D., T. Reed Stephens, Health, Health Care Litigation, Life Sciences - Health
Arnold Friede, Jennifer Geetter, Robert Nicholas, and Paul Radensky had their On the Subject published in the May 30 edition of Health Law 360 regarding the FDA Draft Guidance on certification of compliance with the new FDAAA clinical trial registration and posting regime.
Arnold I. Friede, Jennifer S. Geetter, Robert B. Nicholas, Paul W. Radensky M.D., Health, Life Sciences - Health
Arnold Friede, Elizabeth Hack, Robert Nicholas, Paul Radensky and T. Reed Stephens were mentioned in a May 29 article in FDA Webview regarding the recent White Paper they had authored regarding Merck’s $58 million settlement of consumer fraud claims by state attorneys general.
Arnold I. Friede, Elizabeth I. Hack, Robert B. Nicholas, Paul W. Radensky M.D., T. Reed Stephens, Health, Life Sciences - FDA, Life Sciences - Health
2007
Paul W. Radensky was quoted in the December 2007 issue of Biotechnology Healthcare in an article regarding IVDMIA guidance. "Assays are not defined in the Food, Drug and Cosmetic Act or any other regulation. In effect, the guidance is being promulgated as if it were a rule, even though guidances are not supposed to be binding. The Health and Human Services secretary has reportedly stated that the FDA would not enforce the IVDMIA guidance before any policy," Mr. Radensky said.
Paul Radensky was quoted in the July 2007 issue of Clinical Lab Products Magazine in an article regarding the new FDA draft guidance regarding in vitro diagnostic multivariate index assays (IVDMIAs). "I think you get universal agreement, including the FDA, that what was put in the September draft guidance was not clear,"Mr. Radensky said.
Paul W. Radensky M.D., Health, Life Sciences - Health
Paul Radensky was quoted in the March 9 issue of the Silicon Valley/San Jose Business Journal in an article regarding the draft regulations from the FDA on genetic testing laboratories. "This is a major, substantive change in the rules and it should go through regular rule-making procedures. There are a number of provisions, when you have rule-making, in which the FDA has to explain the impact on small businesses. These are important protections that you don’t have from a draft guidance," Mr. Radensky said.
Paul Radensky was quoted in the February 14 issue of Pharmacogenomics Reporter in an article regarding the U.S. Food and Drug Administration's proposition to regulate a subset or complex laboratory-developed genetic tests. "The draft guidance raises ‘concerns over FDA's legal authority to regulate clinical laboratories,' is unclear over the definition of in vitro diagnostic multivariate index assays, and does not clearly identify the elements of an IVDMIA that comprise a medical device subject to FDA regulation versus those regulated under CLIA," Mr. Radensky said.
Paul Radensky was quoted in the February 12 issue of Medical Device Week in an article regarding published guidance for in vitro diagnostic multivariate index assays (IVDMIAs or MIAs). "Guidance has raised a large number of issues, including FDA's authority to regulate these assays. Other issues include how the quality system regulations (QSRs) mesh with the Clinical Laboratory Improvement Amendments (CLIA) standards, which are overseen by the CMS," Mr. Radensky said.
Paul Radensky was quoted in the February 12 issue of The Gray Sheet in an article regarding laboratory stakeholders urging the FDA to ditch in vitro diagnostic multivariate index assays. "It's not all clear what an IVDMIA is. It begs the question to simply says, 'It's different,'" said Mr. Radensky.
2004
Global Counsel 3000 (Practical Law), a law-related resource site, recently recommended MWE's Miami office as a top firm for Company and Corporate Transactions, where the office is a leader in health care transactions. In addition, Paul Radensky was recommended nationally for his work in the Life Sciences/Regulatory area.
Paul W. Radensky M.D., Corporate, Life Sciences & Medical Devices
