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Designed specifically for the experienced regulatory professional, the RAPS Executive Development program builds key management, business and leadership skills through intense discussions with some of the world’s best business professors in an intimate learning environment at the Kellogg School of Management.
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.
As drug price increases continue to make waves on the national level, Congress is taking the matter into its own hands by requiring generic drugmakers under the Medicaid Drug Rebate Program to pay higher rebates if generic prices rise too quickly.
As the push for personalized medicine garners more attention, the European Medicines Agency (EMA) on Monday released new draft guidance to provide industry with more insight on how to identify and understand genomic factors that influence drug responses.
Although the total workload of abbreviated new drug applications (ANDAs) continues to rise, the number of ANDAs currently with the US Food and Drug Administration (FDA) has declined by about 160 ANDAs over the past three months, according the agency’s second generic drug review dashboard released on Monday.
RAPS has opened the nomination process for four open positions on its board of directors for the 2017–19 term. Nominations and supporting materials must be submitted to RAPS by 1 June 2016.
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Another day, another issue with data integrity. This time, however, the US Food and Drug Administration (FDA) is taking the issue one step further and notifying sponsors of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) that clinical and bioanalytical studies conducted by Bangalore, India-based contract research organization (CRO) Semler Research are not acceptable as a result of data integrity concerns and need to be repeated. View More
The US Food and Drug Administration (FDA) last week released an inspection report citing major deficiencies at pharmaceutical contract manufacturer Catalent's Saint Petersburg, FL facility. View More
Drug regulators from the US, Europe, Canada, France, Netherlands, Germany and Switzerland are attempting to build a database of substances used in medicinal products to ease the exchange of such information. View More
Following a contentious debate pitting young boys with the terminal illness Duchene Muscular Dystrophy (DMD) against the US Food and Drug Administration (FDA), an advisory panel of outside experts on Monday voted against the approval of Sarepta Therapeutics’ controversial investigational drug eteplirsen to treat DMD. View More