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RAPS Virtual Career Fairs are designed to connect employees with employers no matter where they might be located.
Local or global—RAPS has you covered with offices in Washington, DC, Shanghai and Singapore. There are RAPS chapters in Canada, Israel, Switzerland, Taiwan and throughout the United States, and local networks in Australia, Belgium, Brazil, Germany, India, Mexico, The Netherlands, Poland and Singapore.
Regulatory Exchange, aka RegEx, is where members come online to learn, grow and engage with a diverse global community of regulatory professionals with similar interests and goals.
It’s well-known that the National Institutes of Health (NIH) offers billions of dollars in grants to US academic research facilities. What’s less well-known is that each year, hundreds of new inventions are produced in the laboratories of NIH, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), and these inventions are licensed out to private companies in the US and internationally for further research and development, with the hopes of bringing new products to market.
The European Medicines Agency (EMA) on Friday said it could find "no clear and consistent" evidence of a difference in the risk of inhibitor development between recombinant and plasma-derived factor VIII medicines.
This profile summarizes the reimbursement process in England, presents key stakeholders and highlights what should be considered early in the development process.
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
This article discusses some basic US reimbursement concepts in the context of the regulatory function and the interplay of the two within the broader business strategy.
Categories: Medical Devices, Reimbursement, Features, US, FDA
Tags: Reimbursement, Centers for Medicaid & Medicare Services, CMS, Payers, Coverage
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The US Food and Drug Administration (FDA) on Wednesday released a Form 483 sent to Korea’s Celltrion with 12 observations, which an industry analyst believes could be the reason why the commercialization of Celltrion and Pfizer’s Inflectra (infliximab-dyyb), a biosimilar to Remicade, has not gone as well as planned in the US. View More
The Department of Homeland Security's Industrial Control Systems Cyber Emergency Response Team (DHS ICS-CERT) on Thursday issued an advisory detailing eight cybersecurity vulnerabilities found in Smiths Medical's Medfusion 4000 wireless infusion pumps. View More
FDA commissioner Scott Gottlieb announced Tuesday that the agency will release guidance to close a loophole that allows companies to avoid their obligation to study pharmaceuticals in pediatric populations. View More
FDA commissioner Scott Gottlieb on Monday explained to attendees of RAPS’ Regulatory Convergence conference some steps FDA is taking to make the clinical end of drug development more efficient and effective. View More