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  • TrackersTrackers

    COVID-19 therapeutics tracker

    More than a year into the pandemic, only a handful of repurposed therapeutics have been approved to treat COVID-19: dexamethasone in the UK and Japan; Avigan (favilavir) in China, Italy and Russia; Veklury (remdesivir) in the US, UK and Japan and Lagevrio (molnupiravir) in the UK.   Regulators around the world have allowed a handful of additional treatments to be used on an emergency-use basis including Eli Lilly and Company’s monoclonal antibodies bamlanivimab with et...
  • Regulatory NewsRegulatory News

    FDA grants states more time to sign compounding MOU before enforcing distribution limits

    The US Food and Drug Administration has agreed to give states a one-year extension to sign a memorandum of understanding (MOU) with the agency to control the distribution of compounded drugs sold interstate.   The 2012 Drug Quality and Security Act (DQSA) amends Section 503A of the Federal Food, Drug and Cosmetics Act (FD&C Act) by requiring states sign a MOU to prevent an “inordinate” number of compounded drugs from being shipped interstate.   States that do not...
  • Regulatory NewsRegulatory News

    EMA recommends bluebird bio's Skysona, seven other medicines

    The European Medicines Agency (EMA) issued a favorable opinion for bluebird bio’s Skysona (elivaldogene autotemcel), a gene therapy that treats early cerebral adrenoleukodystrophy (CALD). Seven other medicines also received positive recommendations from the agency’s Committee for Medicinal Products for Human Use (CHMP) during its May meeting.   Skysona’s status as an advanced therapy medicinal product (ATMP) means it was first assessed by EMA’s Committee for Advanced T...
  • Regulatory NewsRegulatory News

    Drug labeling authority, UDI program reviewed by Harvard-based researchers

    Two papers in JAMA Internal Medicine highlighted separate, but important issues concerning the US Food and Drug Administration’s authority to modify package inserts and the effect of a recently shuttered agency initiative.   In a Viewpoint, Bishal Gyawali, MD, PhD, and colleagues at the Program on Regulation, Therapeutics and Law (PORTAL) research group at Harvard Medical School and Brigham & Women’s Hospital suggested improving FDA’s authority to modify drug package...
  • Regulatory NewsRegulatory News

    FDA recommends 503B bulks list addition; rejects HCQ sulfate

    The US Food and Drug Administration (FDA) has preliminarily recommended that one additional substance be added to its list of bulk drug substances for outsourcing facilities to use in compounding.   FDA is proposing that quinacrine hydrochloride be added to the list, commonly referred to as the 503B bulks list. This bulk drug substance, while not a component of an FDA-approved drug, is used to compound oral treatments for cutaneous lupus erythematosus. (RELATED: Glyc...
  • ReconRecon

    Recon: Kerfuffle over WHO's Wuhan mission; BMS inks $1.3 B cancer deal

    Recon:   Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US New, Daily Coronavirus Cases Drop Below 100K For First Time In Months ( NPR ) U.S. Continues To Accelerate Vaccination Strategy ( NPR ) Seven coronavirus variants potentially similar to UK type have been detected in US: study ( The Hill ) ( NYT ) Fauci Awarded $1 Million Israeli Prize For 'Speaking Truth To Power' Amid Pandemic ( NPR ) Pentago...
  • Regulatory NewsRegulatory News

    New toolbox available for EMA's PRIME designees

    The European Medicines Agency has released a draft guidance to assist drug developers using its Priority Medicines (PRIME) scheme to accelerate authorization of new therapies.   “Experience to date has shown that applicants face challenges to complete quality and manufacturing development and data requirements during development of products in early access approaches,” wrote EMA in the executive summary of the guidance.   Challenges for those developing breakthroug...
  • Regulatory NewsRegulatory News

    Perspective: Drug price transparency in the Biden era

    The Trump administration’s efforts to increase drug price transparency are likely to survive the transition to the Biden administration, according to a perspective piece published 13 January in the New England Journal of Medicine . Included in the Transparency in Coverage final rule, issued in late October 2020, the drug price transparency provisions aim to require that health insurers publish list prices and historical net prices for prescription drugs. The inform...
  • Regulatory NewsRegulatory News

    EC’s new pharmaceutical strategy highlights support for innovation, R&D

    The European Commission (EC) has adopted its pharmaceutical strategy for Europe. The announcement follows a period of consultation earlier this year and meets the EC’s goal of finalizing the strategy by year’s end.   The strategy is not focused on the COVID-19 pandemic, but strategies and considerations included in the document were informed by the impact of the novel coronavirus in Europe and globally.  The primary objectives of the strategy fall into four categories. ...
  • Regulatory NewsRegulatory News

    Experts propose changes to FDA’s Accelerated Approval Program

    A new white paper from the Friends of Cancer Research offers a blueprint for reimagining the US Food and Drug Administration (FDA) Accelerated Approval Program for drugs and biologics that treat serious and life-threatening illnesses. The white paper , released during the group’s annual meeting, recommends explicitly adding a more comprehensive risk-benefit assessment to the surrogate endpoints currently used as the basis for approval, a framework that would move the U...
  • Regulatory NewsRegulatory News

    EMA's CHMP gives Gamifant a second thumbs down; approves five new medicines

    In its November meeting, a committee of the European Medicines Agency gave its second thumbs down to the monoclonal antibody Gamifant (emapalumab), confirming a July 2020 negative opinion on the Novimmune SA drug.   The US FDA approved Gamifant for pediatric use in primary hemophagocytic lymphohistiocytosis in November 2018; this was the same indication for which EMA has twice declined authorization.   EMA’s human medicines committee (CHMP) had positive recommendat...
  • Regulatory NewsRegulatory News

    Makena indication may fall based on post-approval data

    The US Food and Drug Administration (FDA) is seeking to withdraw the approval of the only drug indicated to prevent recurrent preterm birth, based on a post-approval study showing a lack of efficacy.   Makena (hydroxyprogesterone caproate injection) was originally granted accelerated approval in 2001 and remains on the market. Makena’s manufacturer, AMAG Pharmaceuticals, has requested a public hearing to explore the issue. It is up to the FDA commissioner whether to gr...