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  • Regulatory NewsRegulatory News

    Australia Releases Updated Drug Schedule

    Australia has updated a legislative instrument designed to advise the country's states and territories on the scheduling and labeling of medicines and poisons. Background In Australia, like in many other countries, medicines and other chemicals are classified in a schedule system. The schedule is organized by the level of regulatory control required for different substances based on their safety and use. The legal basis for drug scheduling in Australia is found in ...
  • Regulatory NewsRegulatory News

    House Passes DEA Reform Bill Changing Definition of When a Drug is 'Approved'

    The US House of Representatives has passed a new bill which promises to accelerate market access for new pharmaceutical products requiring review by the US Drug Enforcement Administration (DEA), and also changes the definition of what drug "approval" means for some new drug products. Background The bill in question, the  Improving Regulatory Transparency for New Medical Therapies Act , is meant to address a regulatory process some drug companies have described as a "b...
  • RAPS' LatestRAPS' Latest

    How to Schedule Your RAC Exam

    One simple but important step in your quest for Regulatory Affairs Certification (RAC) is scheduling your exam. The four RAC exams are computer-based and are offered at testing centers around the world during the April–May and October–November exam periods, so regardless of which exam you wish to take, there will be a number of possible locations and dates available. Once you have registered for the exam of your choice, about 15 days before the exam c...
  • Regulatory NewsRegulatory News

    After New Drugs Delayed by DEA, Legislators Seek Overhaul of Drug Scheduling Process

    For most pharmaceutical products in the US, obtaining approval from the US Food and Drug Administration (FDA) to market a product means a company can begin selling its product as soon as it wants. But for a subset of products subject to the Controlled Substances Act (CSA ) , the Drug Enforcement Administration (DEA)—not FDA—is the ultimate arbiter of when market access occurs and the extent to which it occurs. Now new legislation wants to make the process by which DEA ...
  • Bill Aims to Speed up Regulatory Process for Abuse-Prone Drugs

    A new piece of legislation introduced today by a bipartisan congressional duo calls for the improvement of a current regulatory stumbling block that some companies have likened to a "black hole." Background While the US Food and Drug Administration (FDA) determines whether a drug is safe and effective in the US, the determination of whether its component parts are addictive or prone to abuse falls under the authority of the US Drug Enforcement Administration (DEA) and t...