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Subject / Started by	Replies / Views	Last post
New Medicine - Pediatric Exclusivity Granted Started by pioneer	0 Replies 453 Views	November 20, 2012, 08:03:23 AM by pioneer
New Medicine - FDA Drug Safety Communication: Update on the risk for serious bleeding events with the anticoagulant Pradaxa Started by pioneer	0 Replies 404 Views	November 20, 2012, 08:03:23 AM by pioneer
New Medicine - Started by pioneer	0 Replies 384 Views	November 20, 2012, 08:03:23 AM by pioneer
New Medicine - Truthful Prescription Drug Advertising and Promotion Started by pioneer	0 Replies 337 Views	November 20, 2012, 08:03:23 AM by pioneer
New Medicine - Pediatric Exclusivity Statistics Started by pioneer	0 Replies 407 Views	November 20, 2012, 08:03:24 AM by pioneer
New Medicine - National Drug Code Directory Started by pioneer	0 Replies 347 Views	November 20, 2012, 08:04:05 AM by pioneer
New Medicine - Multistate outbreak of fungal meningitis and other infections Started by pioneer	0 Replies 349 Views	November 20, 2012, 08:04:06 AM by pioneer
New Medicine - Drugs@FDA Data Files Started by pioneer	0 Replies 405 Views	November 20, 2012, 08:04:06 AM by pioneer
New Medicine - Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Amendments Act of 2012 (FDASIA) Started by pioneer	0 Replies 450 Views	November 20, 2012, 08:04:06 AM by pioneer
New Medicine - Medication Guides Started by pioneer	0 Replies 394 Views	November 20, 2012, 08:04:07 AM by pioneer
New Medicine - Additions/Deletions for Prescription and OTC Drug Product Lists Started by pioneer	0 Replies 350 Views	November 20, 2012, 08:04:07 AM by pioneer
New Medicine - Orange Book Zip File Started by pioneer	0 Replies 426 Views	November 20, 2012, 08:04:07 AM by pioneer
New Medicine - Drug Establishment Annual Registration Status Download File Started by pioneer	0 Replies 407 Views	November 20, 2012, 08:04:07 AM by pioneer
New Medicine - Drug Establishments Current Registration Site Started by pioneer	0 Replies 411 Views	November 20, 2012, 08:04:07 AM by pioneer
New Medicine - Newly Added Guidance Documents Started by pioneer	0 Replies 424 Views	November 20, 2012, 08:04:07 AM by pioneer
FDA Update - Jobs at the Center for Biologics Evaluation and Research (CBER) Started by pioneer	0 Replies 360 Views	November 20, 2012, 08:04:07 AM by pioneer
FDA Update - Ducord, HPC Cord Blood Started by pioneer	0 Replies 379 Views	November 20, 2012, 08:04:07 AM by pioneer
FDA Update - Biologic Product Shortages Started by pioneer	0 Replies 384 Views	November 20, 2012, 08:04:07 AM by pioneer
FDA Update - Complete List of Substantially Equivalent 510(k) Device Applications Started by pioneer	0 Replies 337 Views	November 20, 2012, 08:04:07 AM by pioneer
FDA Update - Complete List of Currently Approved Premarket Approvals (PMAs) Started by pioneer	0 Replies 366 Views	November 20, 2012, 08:04:07 AM by pioneer
FDA Update - Complete List of Currently Approved NDA and ANDA Application Submissions Started by pioneer	0 Replies 389 Views	November 20, 2012, 08:04:07 AM by pioneer
FDA Update - Fluarix Started by pioneer	0 Replies 348 Views	November 20, 2012, 08:04:07 AM by pioneer
FDA Latest - Transcripts posted for the September 28, 2012 Ophthalmic Devices Panel meeting Started by pioneer	0 Replies 406 Views	November 20, 2012, 08:04:07 AM by pioneer
FDA Latest - Transcript posted for Sept. 21, 2012 Orthopaedic and Rehabilitation Devices Panel meeting Started by pioneer	0 Replies 427 Views	November 20, 2012, 08:04:07 AM by pioneer
FDA Latest - Class I Medical Device Recall: Stryker Instruments, Neptune Rover Waste Management Systems Started by pioneer	0 Replies 375 Views	November 20, 2012, 08:04:07 AM by pioneer
FDA Latest - Meeting materials posted for October 24, 2012 Radiological Devices Panel of the Medical Devices Advisory Committee Meeting Started by pioneer	0 Replies 570 Views	November 20, 2012, 08:04:07 AM by pioneer
FDA Latest - Class I Medical Device Recall: Ethicon Endo-Surgery, Inc. Proximate PPH Hemorrhoidal Circular Stapler and Accessories 33mm, Proximate HCS Hemorrhoidal Circular Stapler and Accessories 33mm and the Transtar Circular Stapler Procedure Set Started by pioneer	0 Replies 397 Views	November 20, 2012, 08:04:07 AM by pioneer
FDA Latest - Consumer Information on: OVATION Abdominal Stent Graft System - P120006 Started by pioneer	0 Replies 387 Views	November 20, 2012, 08:04:07 AM by pioneer
FDA Latest - Consejos para los dispositivos médicos durante desastres de huracanes de la FDA Started by pioneer	0 Replies 405 Views	November 20, 2012, 08:04:07 AM by pioneer
FDA Latest - Class I Medical Device Recall: Touchscreen for Hospira Symbiq Infusion System, Models 16026 and 16027 Started by pioneer	0 Replies 349 Views	November 20, 2012, 08:04:07 AM by pioneer
FDA Latest - POSTPONED - November 1, 2012: Neurological Devices Panel of the Medical Devices Advisory Committee Meeting Announcement- POSTPONED Started by pioneer	0 Replies 453 Views	November 20, 2012, 08:04:07 AM by pioneer
FDA Latest - Webinar: The Value of UDI Implementation for Healthcare Systems and Providers, November 5, 2012 Started by pioneer	0 Replies 367 Views	November 20, 2012, 08:04:07 AM by pioneer
FDA Latest - Summary Information for: Subcutaneous Implantable Defibrillator (S-ICD) System Started by pioneer	0 Replies 352 Views	November 20, 2012, 08:04:07 AM by pioneer
FDA Latest - Consumer Information on: Subcutaneous Implantable Defibrillator (S-ICD) System - P110042 Started by pioneer	0 Replies 415 Views	November 20, 2012, 08:04:08 AM by pioneer
FDA Latest - Consumer Information on: APTIMA® HPV 16 18/45 Genotype Assay - P120007 Started by pioneer	0 Replies 437 Views	November 20, 2012, 08:04:08 AM by pioneer
FDA Latest - Summary Information for: APTIMA® HPV 16 18/45 Genotype Assay Started by pioneer	0 Replies 407 Views	November 20, 2012, 08:04:08 AM by pioneer
FDA Latest - 20th Anniversary of Mammography Quality Standards Act and Program Started by pioneer	0 Replies 441 Views	November 20, 2012, 08:04:08 AM by pioneer
FDA Latest - Federal Register: Minimum Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and Regulation; Public Workshop Started by pioneer	0 Replies 405 Views	November 20, 2012, 08:04:08 AM by pioneer
FDA Latest - Minimum Clinically Important Difference (MCID): Defining Outcome Metrics for Orthopaedic Devices - Public Meeting, November 27-28, 2012 Started by pioneer	0 Replies 337 Views	November 20, 2012, 08:04:08 AM by pioneer
FDA Latest - Consumer Information on: Edwards SAPIEN Transcatheter Heart Valve (THV) - P110021 Started by pioneer	0 Replies 321 Views	November 20, 2012, 08:04:08 AM by pioneer
FDA Latest - Summary Information for: Edwards SAPIEN Transcatheter Heart Valve (THV) Started by pioneer	0 Replies 403 Views	November 20, 2012, 08:04:08 AM by pioneer
FDA Latest - December 5-6, 2012: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement Started by pioneer	0 Replies 471 Views	November 20, 2012, 08:04:08 AM by pioneer
FDA Latest - Federal Register: Circulatory System Devices Panel of the Medical Devices Advisory Started by pioneer	0 Replies 511 Views	November 20, 2012, 08:04:10 AM by pioneer
FDA Latest - Summary Information for: PCM Cervical Disc System Started by pioneer	0 Replies 378 Views	November 20, 2012, 08:04:10 AM by pioneer
FDA Latest - Consumer Information on: PCM Cervical Disc System - P100012 Started by pioneer	0 Replies 544 Views	November 20, 2012, 08:04:10 AM by pioneer
FDA Latest - Summary Information for: OVATION Abdominal Stent Graft System Started by pioneer	0 Replies 420 Views	November 20, 2012, 08:04:10 AM by pioneer
FDA Latest - Summary Information for: Medtronic Valiant Thoracic Stent Graft with the Captivia Delivery System Started by pioneer	0 Replies 390 Views	November 20, 2012, 08:04:10 AM by pioneer
FDA Latest - Consumer Information on: Medtronic Valiant Thoracic Stent Graft with the Captivia Delivery System - P100040S008 Started by pioneer	0 Replies 395 Views	November 20, 2012, 08:04:10 AM by pioneer
FDA Latest - Summary Information for: Magnetic Resonance guided Focused Ultrasound Surgery System (MRgFUS), ExAblate Model 2000/2100 Started by pioneer	0 Replies 385 Views	November 20, 2012, 08:04:10 AM by pioneer
FDA Latest - Consumer Information on: Magnetic Resonance guided Focused Ultrasound Surgery System (MRgFUS), ExAblate Model 2000/2100 - P110039 Started by pioneer	0 Replies 429 Views	November 20, 2012, 08:04:10 AM by pioneer

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