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Latest Center for Devices and Radiological Health Stories

2014-09-11 23:02:29

Regulators, pharmaceutical, biotechnology and medical device industry leaders, innovators, thought leaders and other regulatory stakeholders will participate in the Regulatory Affairs Professionals Society’s signature annual event. Rockville, MD, USA (PRWEB) September 11, 2014 The practitioners of a profession that has a profound impact on healthcare around the world, but whose work is not well understood by the general public will gather in Austin, TX, this month when the Regulatory...

2014-08-25 08:27:16

FALLS CHURCH, Va., Aug. 25, 2014 /PRNewswire-iReach/ -- 9(th) Annual FDA Inspections Summit **Presented by FDAnews** Oct. 22-24, 2014 - Bethesda, MD www.fdanews.com/9thFDAInspectionsSummit Photo - http://photos.prnewswire.com/prnh/20140822/138921 What's the state of FDA's Quality Metrics Initiative? When will drug and devicemakers have to start collecting data? What will they have to track? And where does the agency stand on the reorganization of its inspectional operations? What will that...

2014-07-29 23:13:58

It’s time for the 9th Annual FDA Inspections Summit, focusing on inspectional readiness. With twin tracks for drug/biologics and device manufacturers, attendees will discover sessions and panels for every FDA-regulated company. Falls Church, VA (PRWEB) July 29, 2014 9th Annual FDA Inspections Summit **Presented by FDAnews** Oct. 22-24, 2014 – Bethesda, MD http://www.fdanews.com/InspectionsSummit2014 What’s the state of FDA’s Quality Metrics Initiative? When will drug and...

2014-07-22 08:24:01

NORTHBROOK, Ill., July 22, 2014 /PRNewswire/ -- UL (Underwriters Laboratories), a global safety science leader, has announced that the U.S. Food and Drug Administration (FDA) has recognized two UL battery safety standards as consensus standards for medical devices incorporating lithium or nickel-based batteries. The two standards are UL 2054 - Standard for Household and Commercial Batteries, and UL 1642 - Standard for Lithium Batteries (Cells)....

2014-07-16 12:27:49

BETHESDA, Md., July 16, 2014 /PRNewswire-USNewswire/ -- The Parenteral Drug Association (PDA) has confirmed FDA's Stephen Ostroff, M.D., Acting Chief Scientist in the Office of the Commissioner will present "FDA's Views on Scientific Advances and their Impact on Manufacturing of the Future" on September 8, 2014 in at the opening plenary session of the 2014 PDA/FDA Joint Regulatory Conference in Washington, DC at the Renaissance Hotel. The Conference dates are September 8-10, 2014,...

2014-06-18 23:08:45

Bellwether Trials Expected to Begin in Either Mid-2015 or Early 2016 DALLAS (PRWEB) June 18, 2014 The national law firm of Baron and Budd reports that the U.S. District Court, District of Massachusetts held a Status Conference on May 9, 2014 in regard to federal multidistrict litigation (MDL) for GranuFlo lawsuits. The Court filed a Joint Status Report stating that, included in the matters discussed during the conference were potential dates for the MDL’s bellwether trials. According to...

2014-06-14 23:01:07

The hot topics for Tuesday, June 17 SAN DIEGO (PRWEB) June 14, 2014 Examine the changing landscape for bioinnovation, the impact of “big data” on vital research partnerships, an initiative that pioneers patients’ access to data, and the growth of human tissue models on microchips on Tuesday, June 17, at the DIA 2014 50th Annual Meeting at the San Diego Convention Center. In addition, the world’s foremost regulators will come together that day to discuss fostering globalization in...

2014-06-11 16:27:10

FALLS CHURCH, Va., June 11, 2014 /PRNewswire-iReach/ -- 11(th) Annual Medical Device Quality Congress: Managing the "Big Five" Quality Concerns **Presented by FDAnews** June 24-26, 2014 - Bethesda, MD http://www.fdanews.com/MDQC2NewFDASpeakers Photo - http://photos.prnewswire.com/prnh/20140610/116829 Two new FDA Speakers are confirmed for the Eleventh Annual Medical Device Quality Congress: -- William MacFarland, Director, Division of Manufacturing and Quality, OC, CDRH, FDA...

2014-05-28 12:33:14

FALLS CHURCH, Va., May 28, 2014 /PRNewswire-iReach/ -- 11(th) Annual Medical Device Quality Congress: Managing the "Big Five" Quality Concerns **Presented by FDAnews** June 24-26, 2014 - Bethesda, MD www.fdanews.com/MDQCKeynoteSpeaker Photo - http://photos.prnewswire.com/prnh/20140528/91797 FDAnews is pleased to announce that Steven Silverman, Director, Office of Compliance, CDRH, FDA has been selected to present the keynote address at the 11(th) Annual Medical Device Quality Congress. As...

2014-05-23 23:09:50

Ashley Brittain Landers of Schlichter, Bogard & Denton, LLP reports that the FDA has issued proposed orders to reclassify transvaginal mesh devices to the classification of high-risk. The attorneys at Schlichter, Bogard & Denton, LLP are offering free and confidential case reviews to those who allege to have suffered serious injuries associated with the use of transvaginal mesh (TVM) devices. St. Louis, MO (PRWEB) May 23, 2014 On April 29, 2014, the FDA issued an immediate release...


Word of the Day
caparison
  • A cloth or covering, more or less ornamented, laid over the saddle or furniture of a horse, especially of a sumpter-horse or horse of state.
  • Clothing, especially sumptuous clothing; equipment; outfit.
  • To cover with a caparison, as a horse.
  • To dress sumptuously; adorn with rich dress.
This word ultimately comes from the Medieval Latin 'cappa,' cloak.
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