The Difficulty in Readability Testing
Since readability testing became a necessity for better patient understanding of leaflets, there has been a plethora of ways to test a leaflet. To the outsider, presenting a leaflet to a participant, asking a set of preset questions and recording the responses could appear to be enough to gauge the user friendliness of a Package Leaflet (PL). However, a simple yes/no dichotomic approach quickly yields an unforeseen variable which can aptly be demonstrated in the following hypothetical situation.
FDA Announces Measures to Improve Generic Drug Access
The Food and Drug Administration (FDA) im March 2004 announced that it will provide more information to the public to help generic drug applicants determine if they are eligible for 180-day marketing exclusivity for their products. This period of marketing exclusivity is generally provided to the first generic drug that challenges a patent for the innovator product.
PharmaBrand Summit 2010
21-23 June 2010, Le Méridien Beach Plaza, Monte-Carlo, Monaco
The PharmaBrand Europe Summit 2010 will bring together senior-level executives from Europe's largest organisations with a select and diversified group of leading edge Solution Providers. Do not miss this opportunity to network with your peers and form new alliances. Get a head start on your competition and start building relationships today.
Biosimilars: Key developments in the regulatory environment
This report examines the structure of the biopharmaceutical industry and the strategic approaches taken to alleviate the threat posed by the biosimilar market. It also provides a comprehensive review of the current legislative and regulatory positions of key geographic regions in addition to evaluating their anticipated future legislative changes and outcomes.
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CLINICAL TRIAL IN INDIA-AN OVERVIEW
Global Pharmaceutical companies based in developed countries are increasingly turning to developing countries and emerging economies around the world for conducting clinical trials. Reduced costs combined with easy availability of patients with varied diseases makes developing countries favourite destinations for clinical research outsourcing.
The whole 9 pages article is available for download at Downloads section of FarmavitaR.com
Negotiating the Emerging Biosimilars Landscape: Key developments in the regulatory environment
As regulatory obstacles to biosimilars development have become increasingly resolved, a growing number of opportunities have been created for generics companies in the biopharmaceutical market, which according to IMS data was valued at $85.9 billion in 2007. Conservative projections estimate that sales of biopharmaceutical products will exceed $135 billion by 2011.
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Regulatory Affairs Support for EU and USA
In collaboration with Regulanet network of regulatory affairs consultants throughout Europe and USA, we keep daily contacts and communication with National Agencies for Medicines and Medical Devices. Beside regulatory we also maintain understanding of the business, scientific and technical background of products.
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