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  • Regulatory NewsRegulatory News

    FDA Drafts Guidance on Developing Drugs for Rare Chronic Digestive Disorder

    The US Food and Drug Administration (FDA) issued draft guidance on Wednesday to aid sponsors in the clinical development of drugs and biologics for the treatment of eosinophilic esophagitis (EoE). The 13-page draft guidance document describes the agency’s clinical trial recommendations for EoE drugs. These relate to trial population and design, safety and efficacy considerations, clinical outcomes assessments, as well as pediatric considerations. The clinical developmen...
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    ICH Seeks to Harmonize Generic Drug Standards

    With an aim to harmonize the technical and scientific standards for generic drugs across borders, the International Council on Harmonization (ICH) on Wednesday released a reflection paper outlining an approach to begin supporting such efforts. The reflection paper offers recommendations to develop a series of ICH guidelines on standards for demonstrating bioequivalence for non-complex and more complex dosage forms and products. It also describes the remit of the Informa...
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    CDRH Fleshes Out Guidance on Application of Least Burdensome Provisions

    The US Food and Drug Administration (FDA) on Monday published final guidance on the FD&C Act’s least burdensome provisions for the regulation of medical devices, highlighting recent initiatives via newly added themes. The 24-page document, which finalizes a draft from December 2017, is intended to reflect guiding principles that require “the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient...
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    House E&C Questions Insulin Manufacturers

    The House Committee on Energy and Commerce (E&C) on Wednesday sent letters to the three insulin manufacturers serving the US: Eli Lilly, Novo Nordisk and Sanofi, seeking more information on the root causes of the rising cost of insulin. First discovered more than 100 years ago, average insulin prices nearly tripled between 2002 and 2013 and then nearly doubled between 2012 and 2016, with patients bearing the brunt of those price spikes. Now, just a day after two moth...
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    House, Senate Hearings Address Pharmaceutical Prices

    The House Oversight Committee and the Senate Finance Committee on Tuesday held hearings addressing the rising cost of prescription drugs, with both committees featuring mothers of insulin-dependent children, including one whose daughter died because of rationing due to the cost of insulin. Senate Finance Chair Chuck Grassley (R-IA) and others stressed the need for an investigation into the rising cost of insulin. “We need to continue to have a strong research engine ...
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    CDRH Outlines Next Steps to Implement New Safety and Performance Based Pathway

    Following Tuesday’s final guidance that established a new option for 510(k) clearance, a spokesperson from the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) highlighted next steps to implement the new Safety and Performance Based Pathway in 2019. “Our next step is to develop an implementation plan to apply this Safety and Performance Based Pathway,” CDRH spokesperson Angela Stark told Focus . “We encourage industry and o...
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    Democrats, Republicans Unveil Drug Pricing Bills

    As a new Congressional term kicks off, Democrats and Republicans in Congress, as well as the Trump administration, are pushing policies to lower prescription drug prices.   On Wednesday, Sens. Chuck Grassley (R-IA) and Amy Klobuchar (D-MN) introduced a bill, dubbed the Safe and Affordable Drugs from Canada Act of 2019, that would allow for Americans to import drugs from Canada. The bill mirrors the bill by the same name championed by the late Sen. John McCain (R-AZ...
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    FDA's Record Year: A Look at 2018 New Drug Approvals

    The US Food and Drug Administration (FDA) set an all-time record for new drug approvals in 2018 with 59 novel drugs and biologics approved by the agency's Center for Drug Evaluation and Research (CDER).   The number of new molecular entities (NMEs) and biologics approved by CDER surpassed the agency's previous record of 53 approvals in 1996 and is a significant jump over the 46 new drugs approved in 2017 . Those figures do not include products approved by FDA's Center...
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    EMA Recommends When Drugmakers Should Consult With Pediatric Research Network

    The European Medicines Agency (EMA) on Monday released recommendations from its European network of pediatric research (Enpr)-EMA working group on opportunities during various stages of development to consult with pediatric research groups.   “Enpr-EMA suggests that all companies consider using these opportunities in a spirit of shared learning about the best way to collaborate during [pediatric investigation plan] planning,” EMA writes, noting that companies can benef...
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    Generic Drug Prices ‘Strongly Predictive’ of Shortages, Study Finds

    How a generic drug is priced may be the difference between whether it experiences a shortage or not, a new study published in Value in Health found. The study of commonly used outpatient generic drugs from 2008 to 2014 found that the prevalence of shortages decreased from a peak in 2011-2012 to less than 4% of the overall sample by the end of 2014. Generic drug prices “were strongly predictive of drug shortages,” the researchers found. But competition and market si...
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    GAO Raises Questions on FDA’s Orphan Drug Designation Process

    The Government Accountability Office (GAO) announced Friday that it has found that the US Food and Drug Administration (FDA) does not always ensure that all information is consistently recorded and evaluated when making orphan drug designation determinations. The missing of these critical steps by the agency in some cases means that FDA reviewers do not fully understand the context of a drug’s intended use for the rare disease, GAO said. “The Commissioner of FDA shou...
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    FDA Spotlights Recent Spike in Drug Shortages

    The US Food and Drug Administration (FDA) is not just seeing an increase in drug shortages but also a spike in the intensity and duration of shortages, according to agency presentations at an FDA/Duke Margolis Center for Health Policy event on Tuesday. Matthew Rosenberg, an economics staffer at FDA, looked at drug shortages in terms of occurrence, duration, intensity and public health impact. Combining data from FDA archives and IQVIA national sales database, Rosenbe...