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Come to Baltimore 24-28 October for the only conference exclusively for regulatory professionals.
King of Prussia, PA10/15/2015
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.
Over the past two decades, the US Food and Drug Administration’s (FDA’s) Center for Drug and Evaluation and Research (CDER) has been developing new, expedited pathways to help bring innovative medical products to market more efficiently. These pathways include fast track designation, accelerated approval, priority review and, more recently, breakthrough therapy. Through these expedited pathways, some products have been approved with fewer clinical data than traditionally are required.
This article discusses the contrasts between regulatory oversight of prescription drug advertising and non-advertising promotion in China.
The US Food and Drug Administration (FDA) on Tuesday again revealed data integrity deviations in India, this time from an inspection of Unimark Remedies' facility in Bavla, India, which produces active pharmaceutical ingredients (APIs) for at least two antibiotics – cephalosporin and carbapenem.
RAPS’ Regulatory Convergence offers attendees more than educational sessions and workshops. A big part of the value of the Convergence—or of any conference—lies in its networking opportunities. To make the best impression you can, and hopefully build long-lasting, mutually beneficial relationships, there are a few networking basics you should keep in mind.
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Citing safety concerns and a recent citizen's petition, US Rep. Rosa DeLauro (D-CT) is calling for the US Food and Drug Administration (FDA) to pull the birth control implant Essure from the market. View More
Pharmaceutical industry groups and nonprofits expressed disappointment Monday over a compromise in the Trans-Pacific Partnership (TPP) on biologics data exclusivity. View More
Late Monday evening, the House of Representatives cleared the final congressional hurdle for a bill that would compensate individuals who participate in clinical trials for rare diseases. View More
The US Food and Drug Administration (FDA) will host a two-day public advisory committee meeting on 27 and 28 October to look into updating a list of bulk drug substances that should not be compounded, and another list of substances that can be compounded. View More