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News reports from FDA Webview (www.fdaweb.com)

ACRO Challenges Patient-centered Research Priorities [328 Words] The Association of Clinical Research Organizations challenges plans made by the Patient-Centered Outcomes Research Institute in setting its priorities. 02/21/2012

FDA Pushes for ‘Standardized’ Electronic Data Submissions [370 Words] A new FDA draft guidance outlines the agency’s recommendation that medical product sponsors and applicants submit study data in a standardized electronic format. 02/21/2012

FDA on How to Handle Unsolicited Requests for Off-label Info [767 Words] CDER’s Office of Prescription Drug Promotion gives DIA conference attendees an analysis of a recently-published guidance on response by firms to unsolicited queries concerning off-label use of their products. 02/21/2012

FDA Accepts Repligen NDA for SecreFlo [284 Words] FDA accepts for review a Repligen NDA for SecreFlo for the improved MRI detection of pancreatic duct abnormalities in patients with pancreatitis. 02/21/2012

FDA Publishes Geriatrics Q&A Guidance [86 Words] 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. 02/21/2012

HHS Racks Up $4.1 billion in FY 2011 Health Fraud Actions [460 Words] 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. 02/21/2012   Novartis GMP Troubles Spread to Canadian Sandoz Unit [286 Words] Novartis’ Sandoz unit shuts down 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. 02/21/2012 Bill Introduced to Transform FDA’s Internal Processes [372 Words] Sen. Kay Hagan introduces legislation she says will transform FDA’s internal processes to speed development of and access to innovative treatments for patients with serious or life-threatening diseases, including rare diseases. 02/15/2012

Office of Special Counsel Probes CDRH E-mail Monitoring [303 Words] The Office of Special Counsel says it is investigating allegations that CDRH monitored whistleblowing employees’ e-mails to the Office of Special Counsel and Congress. 02/15/2012

TV Ad Problems Outweigh Benefits: Executive [326 Words] Former Pfizer R&D president John LaMattina says companies should pull their TV ads in response to consumer objections to them. 02/15/2012

Is FDA Abandoning 2-year MDR Presumption? [578 Words] Attorney Jeffrey Shapiro says that a Philadelphia District Office Warning Letter appears to signal that medical device companies can no longer rely on a 1997 agency guidance supporting a two-year presumption that a device malfunction will no longer cause or contribute to a death or serious injury. 02/15/2012

510(k) Program Performance is Seeing Improvements: Shuren [1391 Words] CDRH director Jeffrey Shuren says the Center is seeing some signs that process improvements under the 510(k) program are positively impacting the approval pathway. 02/15/2012

DePuy Marketed Unapproved Hip Replacement Overseas [506 Words] The New York Times details how DePuy Orthopedics sold a hip replacement device overseas after it failed to win FDA approval. 02/15/2012

FDA Accepts Santarus NDA for Ulcerative Colitis [120 Words] FDA accepts a Santarus, Inc. NDA for Uceris tablets, 9 mg for treating mild to moderate ulcerative colitis. 02/15/2012

Pradaxa and Reglan Safety Signals Probed [469 Words] The latest Institute for Safe Medication Practices QuarterWatch report says significant safety signals for Pradaxa and Reglan were seen in the first quarter of 2010. 02/15/2012

Comments Sought on Info on Blood Cell Separator [50 Words] Federal Register Notice: FDA seeks comments on information about Class 2 special controls for an automated blood cell separator device. 02/15/2012

Comments Sought on Biosimilar Product Requirements [50 Words] Federal Register Notice: FDA seeks comments on information about biosimilar product requirements. 02/15/2012