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Santa Clara, CA8/4/2017
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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 recommended the approval of eight new medicines after its Committee for Medicinal Products for Human Use (CHMP) met to discuss the drugs earlier this week.
The European Medicines Agency (EMA) on Friday said it plans to suspend the marketing authorization for three gadolinium contrast agents and restrict the use of others after a review by the agency's Pharmacovigilance Risk Assessment Committee (PRAC) confirmed evidence of gadolinium accumulation in patients' brains months after being injected.
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
This article discusses the evolution, potential uses and regulatory aspects of gene therapy and includes funding, delivery mechanisms, bioethics and steps toward clinical trial implementation.
Categories: Biologics and biotechnology, Human cell and tissue, Features, US, FDA
Tags: Gene therapy,
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The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) on Thursday unanimously backed the approval of biosimilar versions of two of Roche's top selling cancer drugs, Avastin (bevacizumab) and Herceptin (trastuzumab). View More
The US Food and Drug Administration (FDA) told Focus on Wednesday that the agency is considering labeling changes to include additional ocular inflammatory conditions for three immune checkpoint inhibitors. View More
Following the House of Represenatatives' passage of the bill to reauthorize US Food and Drug Administration (FDA) user fees on Wednesday, the White House doubled down on its earlier call to amend the agreements so that FDA is entirely funded by medical products industries. View More
The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee on Wednesday voted unanimously, 10 to 0, in favor of the benefit-risk profile for the first of a new kind of cancer therapy, known as a Chimeric Antigen Receptor T-cell (CAR-T) therapy. View More