Quantcast

Latest Center for Devices and Radiological Health Stories

2014-04-24 16:29:57

FALLS CHURCH Va., April 24, 2014 /PRNewswire-iReach/ -- Software and Cybersecurity Risk Management for Medical Devices: Learn Best Practices from FDA and Industry Experts **Presented by FDAnews and GessNet** May 21-22, 2014 - Bethesda, MD www.fdanews.com/SoftwareCybersecurity (Photo: http://photos.prnewswire.com/prnh/20140424/78173) This workshop, chaired by internationally renowned expert Fubin Wu and featuring three FDA experts, has been specifically designed to provide devicemakers with...

2014-04-08 16:23:37

Southeastern Medical Device Association (SEMDA) Addressing Reform Impact Head-on ATLANTA, April 8, 2014 /PRNewswire/ -- The 8(th) Annual SEMDA Conference, entitled "Thriving During Healthcare Reform," will feature an industry update by Jeffrey Shuren MD, JD, Director of the FDA's Center for Devices and Radiological Health (CDRH). During his presentation, Dr. Shuren will discuss recent agency programs and their impact on the medical device industry. In addition, Stephen J. Ubl,...

2014-03-31 23:38:39

CDRH has recently overhauled its Office of Compliance — what exactly has changed and what hasn’t? In this exclusive question-and-answer webinar rebroadcast, FDA veteran Steve Niedelman, lead quality systems and compliance consultant to the FDA & Life Sciences practice team at King & Spalding, speaks with Steve Silverman, Director of CDRH’s Office of Compliance, to help device manufacturers understand all the changes. Falls Church, VA (PRWEB) March 31, 2014 CDRH’s Office...

2014-02-20 23:02:10

Maria Isabel Tejero del Rio, MD, PhD, Lead Consumer Safety Officer, Division of Manufacturing and Quality, Office of Compliance, CDRH, FDA is confirmed as the opening Keynote speaker at FDAnews’ Device Supplier Controls Virtual Conference. She will discuss the latest FDA policies and processes regarding supplier controls. Falls Church, VA (PRWEB) February 20, 2014 Device Supplier Controls Does the FDA’s Next 483 Have Your Name on It? **FDAnews Virtual Conference** Feb. 26, 2014 —...

2014-02-10 23:26:09

Many of the problems uncovered during inspections are common and recurring problems within the drug and device industry. In this webinar, Dr. David Lim, an accomplished former FDA official with CDRH and pharma executive, will describe the 29 problems that continually show up in 483s and warning letters, and explain why and how the FDA focuses on them. Falls Church, VA (PRWEB) February 10, 2014 Create an Inspection Readiness Gap Analysis: How to Avoid the FDA’s Top 29 483 Citations...

FDA Regulatory Process Variable
2014-01-22 09:31:53

Rebekah Eliason for redOrbit.com – Your Universe Online According to a recent study, the approval of drugs by the Food and Drug Administration (FDA) is based on widely varying clinical trials between 2005 and 2012. The background from the article states that “FDA review of new drug applications is guided by the Federal Food, Drug, and Cosmetic Act, which requires 'adequate and well controlled investigations' to determine efficacy. Many patients and physicians assume that the safety...

2014-01-14 23:29:12

CDRH has recently overhauled its Office of Compliance — what exactly has changed and what hasn’t? In this exclusive question-and-answer webinar, FDA veteran Steve Niedelman, lead quality systems and compliance consultant to the FDA & Life Sciences practice team at King & Spalding, speaks with Steve Silverman, Director of CDRH’s Office of Compliance, to help device manufacturers understand all the changes. Falls Church, VA (PRWEB) January 14, 2014 CDRH’s Office of...

2013-11-18 23:02:53

More than 30 regional and state organizations urge Congress to end sequestration of industry-paid user fees LA JOLLA, Calif. (PRWEB) November 18, 2013 Today, a coalition of more than 30 state and regional life sciences associations, including the California Healthcare Institute (CHI), sent House and Senate Budget Conferees a letter urging swift action to exempt U.S. Food and Drug Administration (FDA) user fees from sequestration. Last year, passage of the FDA Safety and Innovation Act...

2013-10-18 23:23:17

d’Oliveira & Associates has released a new infographic about the Stryker Oasys recall. The law firm works with some of the more experienced defective device lawyers and there is no fee until a settlement or award is obtained. (PRWEB) October 18, 2013 The Stryker Oasys Occipito-Cervico-Thoracic System is a spinal fusion device that works by holds the vertebrae in place with screws and rods. In February 2004, the FDA gave this medical device premarket approval under its 510(k)...


Word of the Day
pungle
  • To take pains; labor assiduously with little progress.
This word comes from the Spanish 'pongale,' put it.
Related