REMSadvisor.com

World Drug Safety Conference

admin — Wed, 25 Aug 2010 16:43:13 +0000

September 14-17, 2010 in London, UK ~ The in-depth drug safety conference programme covers the detection, analysis and prevention of adverse drug reactions with case studies and industry experiences as well as global regulatory coverage of developments in the US, Japan, Europe, Asia/Pacific, South America and Canada.

At World Drug Safety Congress, Europe you can expect to see speakers from a wide range of countries. There will be case study updates, and we will strive to introduce fresh strategy content as we continue to keep track of the latest developments.

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The Safety Continuum in the Medical Product Life Cycle

remsadvisor — Tue, 24 Aug 2010 18:25:36 +0000

September 22-24, 2010 in Baltimore, MD ~

How will you achieve optimal medical product safety in the US and abroad?During this three-day conference, experts offer strategies to overcome critical drug safety challenges faced through-out a product’s life cycle from premarketing clinical trials all the way to postmarketing safety surveillance/vigilance, and risk management. Participants learn about current regulatory national and international standards, state-of-the art methods and techniques in premarketing testing and evaluation, quality safety-related compliance and procedures, effective signal detection and assessment, adverse event reporting, and the latest risk management approaches in the US and abroad.

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CBI’s 13th Bio/Pharmaceutical and Medical Device Registries and Post Approval Studies Congress

admin — Fri, 20 Aug 2010 18:44:29 +0000

September 28 – 30, 2010 in Princeton , NJ ~ CBI has successfully built and maintained a franchise in the Post-Approval space with unmatched research and industry admired speakers and continues that tradition for 2010!

Post-approval studies continue to be an area of increasing importance given the payor power and regulatory requirements. It is also estimated that outsourcing postmarketing studies exceeds $1 billion (according to Dipti Amin, senior vice president, drug safety and medical affairs, Quintiles – Pharma Outsourcing, Oct. 12, 2009). The 2010 forum examines the evolving post-approval landscape and discusses FMV in Phase IV and Registries, impacts of the Sunshine Act, payor requirements and much more!

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Discussion Forum

admin — Thu, 19 Aug 2010 03:32:19 +0000

Discuss any general REMS related topics here.

FDA Proposes Withdrawal of Low Blood Pressure Drug

remsadvisor — Mon, 16 Aug 2010 18:33:06 +0000

Companies failed to provide evidence of clinical benefit of midodrine hydrochloride

The U.S. Food and Drug Administration today proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done.

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FDA approves ella™ tablets for prescription emergency contraception

remsadvisor — Fri, 13 Aug 2010 18:31:15 +0000

The U.S. Food and Drug Administration today approved ella™ (ulipristal acetate) tablets for emergency contraception. The prescription-only product prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected intercourse. It is not intended for routine use as a contraceptive.

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FDA: Aseptic Meningitis Risk with Use of Seizure Drug Lamictal

remsadvisor — Thu, 12 Aug 2010 18:30:04 +0000

The U.S. Food and Drug Administration today warned that the drug Lamictal (lamotrigine), approved to treat seizures and bipolar disorder, can cause aseptic meningitis, an inflammation of the protective membranes (meninges) that cover the brain and spinal cord not caused by bacterial infection.

The agency is working with the drug’s manufacturer, GlaxoSmithKline, to update the prescribing information and patient medication guide to include this risk.

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FDA Issues Assessments of the 510(k) Program and Use of Science in Decision-Making

remsadvisor — Wed, 04 Aug 2010 18:28:33 +0000

Recommendations focus on innovation, regulatory predictability, and patient safety

The U.S. Food and Drug Administration today issued two comprehensive evaluations containing recommendations that address three key objectives of the agency’s public health mission as it relates to medical devices – foster device innovation, create a more predictable regulatory environment, and enhance device safety.

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FDA Panel Wants Tougher Restrictions on Opioids

admin — Thu, 29 Jul 2010 18:38:16 +0000

By Emily P. Walker, Washington Correspondent, MedPage Today — An FDA advisory committee voted 25-10 to reject the agency’s proposed plan to prevent inappropriate prescribing, misuse, and abuse of extended-release opioid painkillers, saying the plan lacks the teeth to stem the “public health crisis” of opioid addiction, overdose, and death.

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FDA Approves Drug for Chronic Drooling in Children

admin — Wed, 28 Jul 2010 18:31:52 +0000

The U.S. Food and Drug Administration today approved Cuvposa (glycopyrrolate) Oral Solution to treat chronic severe drooling caused by neurologic disorders in children ages 3 years to 16 years.

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