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  • Regulatory NewsRegulatory News

    FDA Finalizes Buprenorphine Drug Development Guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance on developing new types of buprenorphine depot products for medication assisted treatment (MAT) for opioid use disorder amid the ongoing opioid epidemic.   Buprenorphine, along with methodone and naltrexone, are the only drugs approved by FDA to treat opioid use disorder.   Buprenorphine MAT works by reducing patients’ withdrawal symptoms and blocking the euphoric effects of other opioid drug...
  • Regulatory NewsRegulatory News

    Endo Pulls Opioid From US Market at FDA's Request

    Endo International announced Thursday that it will comply with the US Food and Drug Administration’s (FDA) request to remove its opioid Opana ER (oxymorphone hydrochloride extended release) from the US market. FDA made the request 9 June “based on its concern that the benefits of the drug may no longer outweigh its risks” after "a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation.” As a res...
  • Regulatory NewsRegulatory News

    Challenges Providing Pharmaceutical Products to Syrian Refugees

    This article discusses the difficulties encountered by medical personnel working with refugees in Syria and delivering pharmaceutical products. It describes relevant regulatory policy and guidance for drug procurement and quality. Introduction Providing healthcare aid to civilians during war and crisis is a complicated task. The Syrian war has impacted the healthcare system inside Syria and the neighboring countries. Large and small humanitarian organizations have wor...
  • New Legislation Aims to Provide FDA with New Authority to Regulate Compounders

    US Rep. Ed Markey (D-MA) plans to introduce a new piece of legislation he says will give the US Food and Drug Administration (FDA) new authority to regulate compounding pharmacies while still preserving state-level oversight authority. Markey's bill, the Verifying Authority and Legality in Drug (VALID) Compounding Act of 2012 , is an attempt to rectify a "regulatory black hole" responsible for letting through dangerous products that have killed dozens of patients an...
  • Analysis: Compounding Crisis Leaves Regulators With Few Good Options

    Extensive problems with a compounding pharmacy in Massachusetts have left US regulators in a complicated bind: They can err on the side of caution and shut down the company's sister organization until it receives regulatory approval, but doing so would likely exacerbate drug shortages already near record highs thanks to similar shutdowns related to regulatory deficiencies in larger pharmaceutical establishments. The owners of the New England Compounding Center (NECC), th...
  • Congressional Investigators Ramp up Pressure on FDA over Meningitis Outbreak

    What did the US Food and Drug Administration (FDA) know, and when did it know it? That's the question being asked of agency officials this week as legislators with the House Energy and Commerce (E&C) Committee sent FDA a letter asking for all details regarding its oversight of a compounding pharmacy. The E&C Committee is in the midst of investigating the New England Compounding Center, which has been linked to a massive outbreak of meningitis that has thus fa...
  • Regulators Scramble to Contain Compounding Crisis as Industry Scrutinized

    • 16 October 2012
    • By
    The US Food and Drug Administration (FDA) continues to warn consumers and healthcare providers about drugs manufactured by the New England Compounding Center (NECC), saying two additional drugs could be contaminated with dangerous types of fungus. ( Regulatory Focus ) - FDA has warned of two additional drugs potentially infected with either fungal meningitis or aspergillus fumigatus , possibly widening the pool of patients affected by drugs compounded at NECC. The a...
  • FDA Identifies Two Additional Compounded Drugs as Potentially Contaminated

    The US Food and Drug Administration (FDA) issued a statement on 15 October indicating two additional products manufactured by the New England Compounding Center (NECC) could be contaminated by fungal meningitis, further exacerbating an already complex crisis. In its statement, FDA said it was aware of at least one patient potentially associated with an epidural injection of triamcinolone acetonide and two transplant patients who received a cardioplegic solution who hav...
  • Compounding Crisis Continues as Reports Raise Questions of Quality

    • 15 October 2012
    • By
    US regulators continue to scramble to understand the extent of a meningitis outbreak linked to a compounding pharmacy in Massachusetts as the death and infection count continue to rise day by day-an unfortunate side effect of a disease with an incubation period that can last months. ( Reuters ) - The Centers for Disease Control and Prevention has confirmed more than 15 deaths and 200 cases of meningitis from steroid injections manufactured by the New England Compounding ...
  • House Democrats Take Aim at FDA, Call for Agency to Release Information

    The US Food and Drug Administration (FDA) is increasingly finding itself at the center of a burgeoning crisis involving steroid injections compounded by a Massachusetts pharmacy that have so far killed 12 and sickened dozens with meningitis. Two prominent members of the US House of Representative's Energy and Commerce Committee-the House's legislative vehicle for overseeing FDA and the pharmaceutical industry-have aimed their sights squarely on FDA, calling on the agen...
  • As Compounding Crisis Widens, Legislators Propose Regulatory Fixes

    US legislators are scrambling to get to the bottom of a burgeoning crisis involving products compounded at a Massachusetts pharmaceutical compounder's facility that have thus far killed 11 people and infected more than 100, announcing hearings and new legislation meant to plug oversight gaps in the regulatory system. In a 9 October announcement , the House Energy and Commerce Committee said it had requested briefings from both the US Food and Drug Administration (FDA) a...
  • EMA Releases EU-Wide Pharmacovigilance Monitoring Plan

    The European Medicines Agency (EMA) has released an updated management plan to deal with the introduction and proliferation of unsafe medicines into the EU's pharmaceutical supply chain. In its 13 August 2012 posting, EMA explained its plan, dubbed the " regulatory network incident management plan for medicines for human use " has been in operation for nearly three years and applies to all medicines approved within the EU, including those approved by the decentralized an...