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Last updated on April 17, 2014 at 1:21 EDT

Latest FDA Stories

2014-02-26 23:33:46

Jay Crowley, the man who wrote the FDA UDI rule, will lead an in-depth 90-minute webinar focusing on what he views as the top 9 challenges that devicemakers face in complying with the final rule. Implementation is mandated in stages over the next few years, but most companies are nowhere near compliance. Falls Church,VA (PRWEB) February 26, 2014 Top 9 UDI Compliance Challenges: Former FDA UDI Chief Provides Answers **FDAnews Webinar** March 11, 2014 — 1:30 p.m. – 3:00 p.m. EDT...

2014-02-26 23:27:54

National network of attorneys continues to provide complimentary consultations to consumers inquiring about legal options to seek compensation over allegations that Tylenol and other acetaminophens may cause liver damage. San Diego, Ca (PRWEB) February 26, 2014 http://www.resource4thepeople.com/defectivedrugs/acetaminophen.html Resource4thePeople announced today it is alerting consumers to a safety alert* issued by the Food and Drug Administration warning health care professionals to...

2014-02-26 23:24:34

Recently, TOGOHK.com, a famous wholesale supplier of FDA and LFGB silicone gaskets, has happily announced its spring special offer. (PRWEB) February 26, 2014 Recently, TOGOHK.com, a famous wholesale supplier of FDA and LFGB silicone gaskets, has happily announced its spring special offer. In other words, all the company’s silicone products are now provided at discounted prices, up to 30% off. The promotion is especially launched for the global customers. TOGOHK.com has been working in...

2014-02-26 23:02:51

Jumpstarting Brain Tumor Drug Development Coalition hosts seminal workshop with brain tumor patient advocates, leading neuro-oncologists, biopharmaceutical industry representatives, FDA, and NCI to advance strategies for establishing better pathways for therapy evaluation. Bethesda, MD (PRWEB) February 26, 2014 Leaders from key cross-sections of the neuro-oncology community came together at a recent Brain Tumor Clinical Trial Endpoints Workshop to confront a critical challenge in...

2014-02-26 23:02:46

Get five days of hands-on, interactive training at FDA Compliance Bootcamp 2014.The course instructors have trained the FDA's own investigators and some are former FDA investigators themselves. Falls Church, VA (PRWEB) February 26, 2014 FDA Compliance Boot Camp 2014: Validation, Data Security, Quality Risk Management, and Compliance Training April 7 - 11, 2014 – Frederick, MD FDA Compliance Bootcamp 2014 Imagine if it was possible to get inside the head of a working FDA inspector...

2014-02-26 16:28:41

Alliance of Healthcare Providers, Device and Software Makers Says Congress Shouldn't Short-Circuit FDA Progress in Parsing High Risk, Low Risk Apps WASHINGTON, Feb. 26, 2014 /PRNewswire/ -- The following statement is being issued by mHealth Regulatory Coalition: Legislation that would remove a wide range of mobile healthcare applications and other medical software from federal oversight would pose serious, potentially life-threatening risks to patients and consumers. Rather than...

Zohydro FDA Approval Sparks Concerns From Several Groups
2014-02-26 13:58:12

Lee Rannals for redOrbit.com - Your Universe Online A group of 40 organizations have joined together to try and influence the Food and Drug Administration (FDA) to revoke its approval of the prescription drug Zohydro. The group of health care professionals and consumer and addiction treatment groups say they are “echoing the concerns” of members of Congress and the State Attorneys General regarding the FDA’s decision to approve Zohydro for use. “On behalf of consumer safety...

2014-02-26 08:27:36

More information at: http://thesynergytrial.org MILL VALLEY, Calif., Feb. 26, 2014 /PRNewswire/ -- K-PAX Pharmaceuticals is working with Stanford University and several other leading research institutions to perform a Phase II double-blind, placebo-controlled trial to evaluate the safety and efficacy of a currently available FDA-approved medication concurrently administered with a novel mitochondrial support product in order to identify a safe and effective treatment for the chronic...

2014-02-25 23:36:23

With state statutes of limitation set to expire in March 2014, the Arnold Law Firm encourages Fresenius dialysis patients to submit details of their potential case for a free legal consultation regarding their rights and options for pursuing justice for injuries and deaths related to Granuflo and NaturaLyte. SACRAMENTO, CALIF. (PRWEB) February 25, 2014 California class action lawyers at the Arnold Law Firm are continuing to investigate injury claims linked to the hemodialysis drugs...

2014-02-25 23:01:34

More than 30 program offerings will delve into the safety of medicines and clinical practices. Horsham, PA (PRWEB) February 25, 2014 The Food and Drug Administration (FDA) and European Medicines Agency (EMA) will discuss common objectives and challenges in pharmacovigilance and clinical safety at DIA’s Annual Meeting from June 15 to 19 in San Diego. The June 17 session, “FDA-EMA Collaboration in Pharmacovigilance: Common Objectives and Common Challenges,” will focus on joint efforts...