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  • Regulatory NewsRegulatory News

    Legislators have mixed views on whether to classify fentanyl as a schedule I substance

    Members of the House Energy and Commerce’s Subcommittee on Health heard testimony 2 December from a US Food and Drug Administration (FDA) official urging congressional support of an administration plan to permanently place fentanyl in the most restrictive category allowed under the Controlled Substances Act (CSA).    The plan addresses the “pressing need” of the public health crisis posed by fentanyl and its related compounds by placing them by default into schedule ...
  • RoundupsRoundups

    Asia Regulatory Roundup: China Changes Stance on Fake Drugs and Online Sales in Legal Update

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   China Changes Stance on Fake Drugs and Online Sales in Legal Update   China has passed changes to the drug administration law. The revised law, which will come into force at the start of December, requires online sellers of drugs to comply with certain rules and increases the maximum fine for organizations that make and market counterfeit medicines.   The Nationa...
  • Regulatory NewsRegulatory News

    CDER Develops New Method to Evaluate an Opioid’s Safety Risk

    As fentanyl analogs present a major risk to public health, and as these analogs can evade prosecution, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has developed a new computational approach to understand these often-unidentified chemicals better and to assist with drug scheduling. The new approach, called Public Health Assessment via Structural Evaluation (PHASE), can evaluate the similarity of a newly identified drug of ab...
  • Regulatory NewsRegulatory News

    FDA Considers WHO Scheduling Change for 17 Drug Substances

    The US Food and Drug Administration (FDA) on Friday sought public comments to help prepare a response to the World Health Organization (WHO) regarding the abuse liability and diversion of 17 drug substances, many of which are opioids and similar to fentanyl. WHO will consider whether to recommend certain international restrictions be placed on the drugs. Background Section 201 of the Controlled Substances Act (CSA) provides that when WHO notifies the US under Art...
  • Regulatory NewsRegulatory News

    FDA, DOJ Investigate Galena Biopharma’s Former Promotions of Fentanyl

    Galena Biopharma on Monday disclosed in an SEC filing that the US Attorney’s Office for the District of New Jersey and the US Department of Justice (DOJ) are pursuing a criminal investigation, in addition to a previously announced civil investigation, related to the marketing and promotion of its deadly opioid Abstral (fentanyl), which the company sold for $8 million upfront in 2015. The details of the criminal investigation have not been disclosed. “There also have b...