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  • Regulatory NewsRegulatory News

    FDA reiterates support for semi-distributed tracing model under DSCSA

    The US Food and Drug Administration (FDA) recommends that trading partners use the semi-distributed model to trace drug products though the drug distribution chain because of this model’s flexibility and advantages over other data architecture models. The Drug Supply Chain Security Act (DSCSA) requires that trading partners have these systems in place by November 2023.   Connie Jung, acting associate director for policy and compliance in FDA’s Office of Drug Security, ...
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    With Drug Shortages in Mind, UK Looks to Block Some Parallel Exports

    As part of efforts to prevent drug shortages ahead of a possible no-deal Brexit, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday published a list of 24 medicines that cannot be parallel exported from the UK. The list includes drugs like the hormone therapies estradiol and levonorgestrel, the antiviral oseltamivir, adrenaline, the blood thinner rivaroxaban and the high blood pressure medicine prazosin, among others. The reason why the UK...
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    EMA Expands Online Portal for Parallel Distribution Submissions

    The European Medicines Agency (EMA) on Monday announced that going forward, parallel distributors will be required to use its recently launched secure online portal, known as Iris, to manage and submit parallel distribution notifications.   Background   Parallel distribution, also known as re-exportation, is a process by which companies in the EU distribute centrally authorized medicines between member states, independent of their marketing authorization holder (...
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    Barriers to FDA and CMS Parallel Reviews: Fear and Bandwidth, Shuren Says

    Medical device companies should want to streamline the process of getting their products reviewed simultaneously by the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Centers for Medicare and Medicaid Services (CMS) - so why aren’t they? Jeff Shuren, director of CDRH late Monday told attendees of JP Morgan’s annual conference that he thinks fear and a limited amount of CMS staff are two reasons that the parallel review ...
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    FDA, CMS: Second Parallel Review Decision Ever for NGS Test

    The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) on Thursday announced joint approval and coverage decisions for Foundation Medicine's FoundationOne CDx next generation sequencing (NGS) based test. The test was reviewed under FDA and CMS' parallel review program, and is only the second test to be approved and cleared under the program since its inception in 2011, the first being Exact Sciences' Cologuard colorectal cance...
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    EMA, EUnetHTA Sign Off on Three-Year Work Plan

    The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) on Monday detailed their priorities for the next three years in a joint work plan. Much of the 2017-2020 work plan builds on previous and ongoing efforts to streamline processes between regulators and health technology assessment (HTA) bodies. "By working together, EMA and EUnetHTA help medicine developers to improve clinical research and become more efficient in...
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    Drug Supply Chain Security: New APEC Toolkit to Aid Collaboration

    With the pharmaceutical supply chain becoming more global and complex, regulators, industry groups and academics from around the world have developed a new toolkit of resources to increase harmonization across borders to ensure the quality of drugs from manufacture through ingestion. The new toolkit, born out of a five-year collaborative project that actually took four years to complete, brings expertise from the US Pharmacopeial Convention (USP), US Food and Drug Admin...
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    House Committee Probes Restricted Distribution Systems Delaying Generics

    • 24 March 2017
    The House Committee on Oversight & Government Reform on Wednesday heard testimony on how pharmaceutical companies use restricted distribution systems to delay generic drug competition. In his opening statement, Subcommittee on Health Care, Benefits and Administrative Rules Chairman Rep. Jim Jordan (R-OH) said that some drugmakers are manipulating the regulatory framework to block competitors from accessing the reference drugs they need to conduct bioequivalence testing t...
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    FDA and CMS Parallel Reviews of Devices to Continue

    A pilot program intended to reduce the time between clearance and Medicare coverage for innovative medical devices will continue on indefinitely, the US Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) announced on Friday. The program, known as parallel review, allows device makers to request a simultaneous, overlapping review by the two agencies with the goal of reducing the time between receiving a pre-market approval (PMA) or t...
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    NICE to Charge up to £282,000 for Each New Drug Assessment

    The UK’s National Institute of Health and Care Excellence (NICE) plans to charge pharmaceutical companies new fees of up to £282,000 for each cost-effectiveness assessment for a new medicine beginning next year. News of the new fees stirred controversy in London’s Sunday Times , and a NICE spokesman emailed Focus on Monday with NICE Chief Executive Sir Andrew Dillon’s response to that story on the fees for technology appraisal and guidance: “Charging pharmaceutica...
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    Asia Regulatory Roundup: CFDA Offers Guidance on Revised Vaccine Distribution Regulations (21 June 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Posts Guide to Implementing Revised Vaccine Distribution Regulations China Food and Drug Administration (CFDA) has released a guide to the implementation of its revised vaccine procurement and distribution regulations. The updated policy calls for vigilant record keeping by organizations in the supply chain and stronger regulatory oversight of each step in the pr...
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    FDA Looks to Bring Payers to the Table at Device Pre-submission Meetings

    The US Food and Drug Administration (FDA) is calling on private health insurers and other payer groups that use clinical data to inform coverage decisions to participate in medical device pre-submission meetings to facilitate timelier access to new devices. The agency believes that including coverage organizations, such as private insurers and health technology assessment (HTA) bodies, early on will allow those organizations to discuss clinical trial design and evidence ...