This year, Congress will have to reauthorize the Prescription Drug User Fee Act (PDUFA), which funds the Food and Drug Administration’s (FDA) drug approval process. As noted by Amanda Kronquist, a Heritage Health Policy Graduate Fellow, the FDA drug approval process has become “increasingly unpredictable, uncertain, and inefficient.”...
The European Medicines Agency, together with the European Union member states and the European Commission, is preparing for the introduction of the new pharmacovigilance legislation in July this year, which will bring the biggest change to the legal framework since the establishment of the Agency in 1995. Over the next five months, the Agency says it will finalize its preparations for the inaugural meeting of the new Pharmacovigilance Risk Assessment Committee (PRAC), planned for July 19, 2012...
inVentiv Medical Management, an inVentiv Health company and leading provider of physician-directed, nurse-supported and technology-enabled medical management solutions, announced today the national launch of a series of new solutions that help to prevent the inappropriate and ineffective care often associated with some of the most complex and costly health conditions...
The medical marijuana drug Sativex, which could be approved in the United States in the coming years as a treatment for pain relief, has little potential for abuse, experts say...
The Pharmaceutical Research and Manufacturers of America (PhRMA) and the Centre for Innovation in Regulatory Science, Ltd. (CIRS) have announced that PhRMA has transferred its Benefit-Risk Action Team (BRAT) framework to CIRS in order to further the program’s technical development and broaden input from the scientific community...
You're taking a new medication and have dry mouth and feel dizzy. Want to know how many other people have reported those side effects—and how your drug compares with similar drugs? The U.S. Food and Drug Administration has millions of such "adverse event" reports, ranging from fatigue to fatal heart attacks, for thousands of prescription drugs dating back to 1969. But the information hasn't been readily accessible—until now...
The U.S. Food and Drug Administration today granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (
GIST). Today's action also highlights an increase in overall patient survival when the drug is taken for 36 months rather than the standard 12 months of treatment...
Read more here: http://www.sacbee.com/2012/01/31/4229004/fda-approves-gleevec-for-expanded.html#storylink=cpy
A goal to standardize risk evaluation and mitigation strategies and modernize the U.S. drug safety system in a proposed reauthorization of the Prescription Drug User Fee Act has drawn support from the country's main chain retail pharmacy lobby...
Health regulators approved Vertex Pharmaceuticals' Kalydeco, the first drug designed to treat the underlying cause of cystic fibrosis, a rare genetic disease...
Amylin Pharmaceuticals won federal approval on Friday for its new, more convenient drug for Type 2 diabetes, ending years of setbacks...
Drug Safety Alliance, Inc., a privately held, woman-owned business, is helping life-science partners gain new agility in responding to change with safety and pharmacovigilance solutions that blend industry knowledge, targeted services, technology and functional expertise. The company will sponsor and present at the DIA Pharmacovigilance and Risk Management Strategies meeting on Monday, January 23 through Wednesday...
A demonstration project at nine hospitals in southern Pennsylvania, aimed at improving the safe use of hydromorphone through a combination of educational programs, computerized order entry improvements and enhanced prescribing oversight, has yielded mixed results, according to its developers...
The poppy is a stunning flowering plant, with a species of flower (opium poppy) that yields a natural agonist for the μ-opioid receptor. This receptor is a G-protein coupled receptor found extensively in the brain and spinal cord, whereby activation causes potent analgesia, with such ancillary effects as sedation, respiratory depression, itching, constipation, nausea and dependence, among others...
To head off medical conflicts of interest, the Obama administration is poised to require drug companies to disclose the payments they make to doctors for research, consulting, speaking, travel and entertainment...
U.S. health regulators said on Friday they have submitted to Congress new recommendations for how manufacturers will help fund their review of new branded drugs, conventional generic medicines and a new generation of generic biotech treatments...
The U.S. Food and Drug Administration (FDA) is notifying the public that two additional cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in death, have been reported with the lymphoma drug Adcetris (brentuximab vedotin). Due to the serious nature of PML, a new Boxed Warning highlighting this risk has been added to the drug label. At the time of Adcetris' approval in August 2011, one case of PML was described in the Warnings and Precautions section of the label...
A second drug company has confirmed it plans to market a new form of the powerful and addictive painkiller hydrocodone, worrying experts who fear a narcotics "arms race" that could worsen a national problem with prescription drug abuse...
Sen. Charles Schumer (D-N.Y.) is urging federal regulators to be extra cautious as they decide whether to approve new super-potent painkillers...
Vivus Inc said U.S. health regulators asked the company to remove a contraindication in the proposed label of its obesity drug Qnexa, a move that could help it reach a broader patient population...
VIVUS, Inc. today announced that following recent discussions with Food and Drug Administration (FDA) officials, the company has been asked to remove the Qnexa® contraindication for women of childbearing potential contained in the proposed label. Qnexa would remain contraindicated for women who are pregnant. A contraindication typically indicates that a drug should not be used because the risk of use clearly outweighs any possible therapeutic benefit...
New York Sen. Kristen Gillibrand is accusing federal agencies of dragging their feet on a decision over whether to tighten controls on the addictive painkiller hydrocodone...
Bayer HealthCare is working with the Ludwig Boltzmann Institute (LBI) for Lung Vascular Research in the research area of lung vascular diseases - especially pulmonary hypertension...
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