 FDA Mandates Stronger Fungal Warning on TNF BlockersThe FDA told manufacturers of four tumor necrosis factor (TNF)-alpha blockers used to treat arthritis and other immune disorders to strengthen warnings on patients’ risk of developing opportunistic fungal infections after reports of 12 deaths of patients taking the drugs. Read More
FDA Warns Sandoz for Continuing Distribution of Generic Toprol XLThe FDA questioned a decision by Novartis subsidiary Sandoz to continue distributing generic versions of Toprol XL before implementing better process controls and completing process validation. Read More
Although Barred From Study, Patient Must Get the DrugPTC Therapeutics is appealing a federal judge’s ruling that orders it to give an experimental treatment undergoing clinical trials to a 16-year-old boy with Duchenne’s muscular dystrophy. Read More
International Standards Under Way to Prevent Tubing MisconnectionsTo minimize the risk of life-threatening tubing misconnections, an Association for the Advancement of Medical Instrumentation working group and an International Organization for Standardization committee are developing standards to create engineering controls that would make a tubing misconnection physically obvious to people who use mismatched tubing sets. Read More
Zimmer to Acquire Abbott’s Spine UnitZimmer Holdings will acquire Abbott Labs’ spinal business for roughly $360 million in cash. Read More
IRB Lacked Written Procedures, FDA SaysA hospital’s institutional review board (IRB) that oversees device clinical trials received a warning letter for violating FDA regulations and its own written procedures. Read More
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International Standards Under Way to Prevent Tubing MisconnectionsTo minimize the risk of life-threatening tubing misconnections, an Association for the Advancement of Medical Instrumentation working group and an International Organization for Standardization committee are developing standards to create engineering controls that would make a tubing misconnection physically obvious to people who use mismatched tubing sets. Read More
Zimmer to Acquire Abbott’s Spine UnitZimmer Holdings will acquire Abbott Labs’ spinal business for roughly $360 million in cash. Read More
IRB Lacked Written Procedures, FDA SaysA hospital’s institutional review board (IRB) that oversees device clinical trials received a warning letter for violating FDA regulations and its own written procedures. Read More
Report: Latin American Orthopedic Device Market Growing FastReconstructive joint implants are the largest and fastest-growing orthopedic device segment across Latin America, exceeding growth in the U.S. — a fact analysts say will create many opportunities for market entry and expansion. Read More
Endologix Gets Positive Findings on Powerlink System TrialEndologix received promising results from a six-year, patient follow-up clinical trial for the company’s Powerlink System as a minimally invasive treatment for abdominal aortic aneurysms (AAA). Read More
Performance Health Partners With Logic to Design Rehabilitation ToolPerformance Health Technologies has signed an agreement with Logic Product Development to improve the usability and design of its Core:Tx rehabilitation device. Read More
FDA Warns Sandoz for Continuing Distribution of Generic Toprol XLThe FDA questioned a decision by Novartis subsidiary Sandoz to continue distributing generic versions of Toprol XL before implementing better process controls and completing process validation. Read More
Although Barred From Study, Patient Must Get the DrugPTC Therapeutics is appealing a federal judge’s ruling that orders it to give an experimental treatment undergoing clinical trials to a 16-year-old boy with Duchenne’s muscular dystrophy. Read More
Norvir Label Updated With New PrecautionPhysician labeling for Abbott Laboratories’ protease inhibitor Norvir has been updated to include a new precaution for patients with cardiac disease regarding a disturbance of heart rhythm or atrioventricular (AV) block called PR prolongation. Read More
Report: CMS Should Explore Options to Address Price DiscrepanciesThe Medicare payment for the colon cancer drug irinotecan was more than double the calculated average manufacturer sales price in March despite the availability of generic alternatives, a report by HHS’ Office of Inspector General (OIG) said. Read More
Velcade Therapy Better in Multiple Myeloma PatientsTakeda Pharmaceutical’s Velcade, combined with GlaxoSmithKline’s Alkeran and prednisone, proved superior to the latter two drugs alone in patients with newly diagnosed myeloma who were not eligible for high-dose therapy, according to a study. Read More
Third Annual FDA Inspections Summit
Price: $1,797
Hear top FDA officials and industry leaders provide insight on what to expect in 2009 and how to better manage your inspections and compliance strategies. You'll participate in intensive workshops, listen to keynote presentations by officials and experts and choose among three specialized tracks (drugs/biologics, devices and clinical trials) focusing on the latest inspections strategies.
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Clinical Trials Indemnification Clauses: Pitfalls and Problems to Avoid
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Clinical Trials Indemnification Clauses: Pitfalls and Problems to Avoid is the management report that examines the most problematic areas in negotiating indemnification clauses. This report highlights the key topics you need to address and provides insight into the types of agreements that are generally accepted standards in the industry.
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