FDAnews

Provider of domestic and international regulatory, legislative, and business news and information

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the U.S. Food and Drug Administration (FDA). Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books, special reports, and conferences to stay in compliance with international standards and FDA’s complex and ever-changing regulations to get their products to market faster and boost profits.

Mon, 07/09/2012 - 14:22
FDA Proposes Unique Device Identification System for Medical Devices UDI system could improve quality of information in medical device adverse-events reports
Mon, 07/09/2012 - 14:22
(FDA: Washington, D.C.) -- In response to requirements in legislation that passed Congress with broad bipartisan support, the U.S. Food and Drug Administration (FDA) proposed that most medical devices distributed in the United States carry a unique…
Two Days of ISO 14971 Training March 28–29, 2012, in Boston
Fri, 01/06/2012 - 12:33
(FDAnews: Falls Church, VA) -- Is failure mode and effects analysis (FMEA) the cornerstone of your risk management program? Consider this quote from the Food and Drug Administration’s (FDA) quality systems regulation expert Kim Trautman: “Are FMEA…
2011 Guide to Medical Device Regulations Released Includes full texts of every device-related regulation currently in force
Mon, 11/28/2011 - 13:10
(FDAnews: Falls Church, VA) -- It’s your job to know the FDA’s medical device regulations inside out. But device regulations can be a moving target. Here’s a resource that can help keep them in your sights. In its first revision in three years,…
‘CAPA Is King’ Virtual Conference Dec. 13, 2011, from 10 a.m.–4 p.m. EST
Tue, 11/15/2011 - 12:50
(FDANews: Falls Church, VA) -- FDAnews has announced details of its upcoming CAPA is King Virtual Conference: Tools, Tips, and Techniques for Assuring Compliance, to be held online Dec., 13, 2011, 10 a.m.–4 p.m. EST. These days more than two-…
Fourth Annual Risk Management and Drug Safety Summit Nov. 1–2, 2011, in Washington D.C.
Tue, 10/18/2011 - 11:24
(FDAnews: Falls Church, VA) -- FDAnews has announced details of its upcoming 4th Annual Risk Management and Drug Safety Summit: Building an Effective Global Risk Management and Drug Safety Program, scheduled for Nov. 1–2, 2011, in Washington D.C…
From Training to Learning: Improving GMP Performance Interactive workshop reveals most efficient way to convey GMP knowledge to staff
Thu, 10/06/2011 - 09:51
(FDAnews: Falls Church, VA) -- FDAnews and LearningPlus are presenting an interactive workshop, From Training to Learning: Improving GMP Performance, to be held Oct. 26–27, 2011 in Raleigh, North Carolina. Click here to register and for further…
Clinical Quality Assurance Roles and Responsibilities for Auditors and Managers Nov. 7–8, 2011, in Boston
Wed, 10/05/2011 - 14:12
(FDAnews: Falls Church, VA) -- The interactive workshop, Clinical Quality Assurance Roles and Responsibilities for Auditors and Managers, scheduled for Nov. 7–8, 2011, at the Radisson Hotel in Boston, is presented by MSceppa Consulting, provider…
Third Annual Supplier Quality Management Congress Aug. 9–11, 2011, in Bethesda, MD
Tue, 06/28/2011 - 18:29
(FDAnews: Falls Church, VA) -- Despite the FDA’s ongoing work with international regulators to improve supplier quality issues, a top FDA official has stated that another public health crisis like Heparin, which occurred in 2010 when Baxter…
Event: Eighth Annual Medical Device Quality Congress June 7–9, 2011, in Bethesda, Maryland
Thu, 05/26/2011 - 14:22
(FDAnews: Falls Church, VA) -- Register today for the Eighth Annual Medical Device Quality Congress, scheduled for June 8–9, 2011, in Bethesda, Maryland. This year the conference will feature more than 15 in-depth sessions headed up by leading…
2011 Nine-Volume Title 21 CFR Set Available to Order Update your library now
Mon, 04/04/2011 - 12:07
(FDANews: Falls Church, VA) -- The federal government has just updated and compiled the new nine-volume Title 21 Code of Federal Regulations (CFR) set for 2011 with all the Food and Drug Administration (FDA) rules for drugs, devices, and biologics…