The leading publisher of FDA News, FDA Review, FDA Compliance, QSR News, and Food Drug Administration information since 1984. http://fdaweb.com/ Wed, 22 Feb 2012 13:03:14 -0600 http://fdaweb.com/login.php?sa=v&aid=D5120876 A Center for Public Integrity investigative report faults FDA for not doing more in the wake of reports that surgical instruments are not being properly cleaned before re-use. Wed, 22 Feb 2012 06:53:00 -0600 http://fdaweb.com/login.php?sa=v&aid=D5120876 http://fdaweb.com/login.php?sa=v&aid=D5120875 FDA grants orphan drug designations for Arno Therapeutics' AR-42 and its use in treating meningioma and schwannoma of the central nervous system. Wed, 22 Feb 2012 06:45:00 -0600 http://fdaweb.com/login.php?sa=v&aid=D5120875 http://fdaweb.com/login.php?sa=v&aid=D5120874 FDA accepts for review a Galderm Labs supplemental NDA for Pliaglis to reintroduce the product after it was withdrawn in 2008 due to manufacturing issues at a contract manufacturer. Wed, 22 Feb 2012 06:42:00 -0600 http://fdaweb.com/login.php?sa=v&aid=D5120874 http://fdaweb.com/login.php?sa=v&aid=D5120873 UCB begins a Phase 3 trial involving Cimzia (certolizumab pegol) in combination with methotrexate for inducing and sustaining clinical response in adults with early, progressive, active, moderate-to-severe rheumatoid arthritis. Wed, 22 Feb 2012 05:48:00 -0600 http://fdaweb.com/login.php?sa=v&aid=D5120873 http://fdaweb.com/login.php?sa=v&aid=D5120872 A CDRH staffer's email to a lawyer confirms that HHS in December blocked a Center decision on the safety of mercury-based dental amalgam from being announced as promised by the end of 2011. Wed, 22 Feb 2012 02:24:00 -0600 http://fdaweb.com/login.php?sa=v&aid=D5120872 http://fdaweb.com/login.php?sa=v&aid=D5120871 Editor Jim Dickinson reviews the current under-the-radar invasion of FDA science by HHS operatives and urges that It is past time to separate the agency from its political overlords. Tue, 21 Feb 2012 14:33:00 -0600 http://fdaweb.com/login.php?sa=v&aid=D5120871 http://fdaweb.com/login.php?sa=v&aid=D5120870 The Association of Clinical Research Organizations challenges plans made by the Patient-Centered Outcomes Research Institute in setting its priorities. Tue, 21 Feb 2012 11:24:00 -0600 http://fdaweb.com/login.php?sa=v&aid=D5120870 http://fdaweb.com/login.php?sa=v&aid=D5120869 In its latest batch of Warning Letters, FDA cites BioElectronics, Intelligent Hospital Systems, and Probed Medical Technologies. Tue, 21 Feb 2012 10:42:00 -0600 http://fdaweb.com/login.php?sa=v&aid=D5120869 http://fdaweb.com/login.php?sa=v&aid=D5120868 Federal Register Notice: FDA releases an ICH guidance, E7 Studies in Support of Special Populations: Geriatrics; Questions and Answers. Tue, 21 Feb 2012 10:35:00 -0600 http://fdaweb.com/login.php?sa=v&aid=D5120868 http://fdaweb.com/login.php?sa=v&aid=D5120867 Federal Register Notice: FDA releases a guidance on chemistry, manufacturing, and control information in early clinical trials for live biotherapeutic products. Tue, 21 Feb 2012 10:34:00 -0600 http://fdaweb.com/login.php?sa=v&aid=D5120867 http://fdaweb.com/login.php?sa=v&aid=D5120866 Federal Register Notice: FDA releases a revised draft guidance on drug interaction studies for NDAs and BLAs. Tue, 21 Feb 2012 10:33:00 -0600 http://fdaweb.com/login.php?sa=v&aid=D5120866 http://fdaweb.com/login.php?sa=v&aid=D5120865 Federal Register Notice: FDA releases a draft guidance: Providing Submissions in Electronic Format — Standardized Study Data. Tue, 21 Feb 2012 10:31:00 -0600 http://fdaweb.com/login.php?sa=v&aid=D5120865 http://fdaweb.com/login.php?sa=v&aid=D5120864 Federal Register Notice: FDA determines that Requip XL ER tablets, 3 mg were not withdrawn from sale for reasons of safety or effectiveness. Tue, 21 Feb 2012 10:29:00 -0600 http://fdaweb.com/login.php?sa=v&aid=D5120864 http://fdaweb.com/login.php?sa=v&aid=D5120863 FDA publishes an ICH guidance on clinical trials in geriatric populations to answer questions that have arisen since an initial guidance on the topic was finalized. Tue, 21 Feb 2012 08:38:00 -0600 http://fdaweb.com/login.php?sa=v&aid=D5120863 http://fdaweb.com/login.php?sa=v&aid=D5120862 FDA Review posts product approval summaries for the week ending 2/17. Tue, 21 Feb 2012 08:26:00 -0600 http://fdaweb.com/login.php?sa=v&aid=D5120862 http://fdaweb.com/login.php?sa=v&aid=D5120861 Industry news you may have missed since our last issue. Tue, 21 Feb 2012 08:23:00 -0600 http://fdaweb.com/login.php?sa=v&aid=D5120861 http://fdaweb.com/login.php?sa=v&aid=D5120860 Mylan says it has resolved defamation litigation against the Pittsburgh Post-Gazette. Tue, 21 Feb 2012 08:11:00 -0600 http://fdaweb.com/login.php?sa=v&aid=D5120860 http://fdaweb.com/login.php?sa=v&aid=D5120859 FDA accepts for review a Repligen NDA for SecreFlo for the improved MRI detection of pancreatic duct abnormalities in patients with pancreatitis. Tue, 21 Feb 2012 07:24:00 -0600 http://fdaweb.com/login.php?sa=v&aid=D5120859 http://fdaweb.com/login.php?sa=v&aid=D5120858 Novartis' Sandoz unit suspends some manufacturing at a Canadian drug plant that was cited in a 2011 FDA Warning Letter, which was the basis for an ongoing shutdown at its Lincoln, NE faciltiy, while it corrects GMP problems there. Tue, 21 Feb 2012 07:22:00 -0600 http://fdaweb.com/login.php?sa=v&aid=D5120858 http://fdaweb.com/login.php?sa=v&aid=D5120857 HHS says that of the record $4.1 billion collected in healthcare fraud actions in FY 2011, $1.3 billion came from criminal matters involving the pharmaceutical and device manufacturing industry that saw 21 criminal convictions. Tue, 21 Feb 2012 07:16:00 -0600 http://fdaweb.com/login.php?sa=v&aid=D5120857