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  • Regulatory NewsRegulatory News

    340B: Health System Execs Push Back on Narrowing of Drug Discount Program

    The House Energy & Commerce's subcommittee on Oversight and Investigations on Wednesday discussed the federal 340B drug discount program, which provides participating hospitals and other medical providers deep discounts on outpatient drugs.  Background In 1992, Congress created the 340B program to mandate that pharmaceutical manufacturers provide discounts for certain drugs, which can range between 25% and 50% for average wholesale prices. The Health Services and ...
  • Regulatory NewsRegulatory News

    EMA Plots New Ways to Help Small and Medium-Sized Pharma Firms

    The European Medicines Agency (EMA) on Wednesday published an action plan for the next three years to help small and medium-sized pharmaceutical companies. The plan seeks to support such companies through all stages of drug development and to further engage with sectors adjacent to pharmaceuticals (e.g. companion diagnostic technologies, medical technologies industries and digital health) in light of Europe’s new medical device legislation , advances in pharmaco...
  • Regulatory NewsRegulatory News

    EMA to Pharma Companies: Prepare for UK to EU Shift

    Setting the stage for a likely exodus from the UK for pharmaceutical manufacturers and staff, the European Medicines Agency (EMA) on Tuesday notified marketing authorization holders (MAHs) that for centrally authorized products, EU law requires them to be established in the EU or European Economic Area, which includes Iceland, Liechtenstein and Norway. EMA also notified MAHs that some of their activities must be performed in the EU (or EEA), related for example to ...
  • Regulatory NewsRegulatory News

    Regulatory Misconduct: FDA Launches Website for Allegations Against Device Manufacturers

    A little more than a week after a scathing report in the Minneapolis Star-Tribune revealed the US Food and Drug Administration (FDA) has accepted late adverse event reports from device companies for hundreds of thousands of incidents, and the agency on Monday launched a new website for regulatory misconduct allegations. The webpage, Allegations of Regulatory Misconduct , allows anyone to submit a claim (via a new, simplified online form ) if it is believed that a me...
  • Regulatory NewsRegulatory News

    Sanders and Cummings Question $80,000 Price Hike of Ariad Cancer Drug

    Sen. Bernie Sanders (D-VT) and Rep. Elijah Cummings (D-MD) on Thursday questioned Ariad Pharmaceuticals CEO Paris Panayiotopoulous after the drugmaker hiked the price of its leukemia treatment by more than $80,000 in four years. The letter follows an exposé earlier this month in TheStreet , in which the company was called out for four price hikes of the leukemia drug Iclusig (ponatinib). The most recent 8% price hike means Iclusig now costs $16,561 per month, or nearly ...
  • Regulatory NewsRegulatory News

    UK, French Regulators Call Out Two Noncompliant Indian Pharma Sites

    UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and France’s ANSM (National Agency for Medicines and Health Products Safety) have sent notices of noncompliance to two Indian pharmaceutical companies that restrict the dissemination of their products in Europe. In February, ANSM inspected Anuh Pharma’s Maharashtra-based site and uncovered 24 deficiencies, including one that was critical and two that were major. The critical deficiency was linked to the fact...
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    How Many Drug Companies Manage to Get Two New Drugs Approved by FDA? Not Many

    The development of a new pharmaceutical or biopharmaceutical product is a notoriously difficult process. According to industry data compiled by the Tufts Center for the Study of Drug Development, only about one in 10 drugs entering into Phase I clinical trials will ever be approved by the US Food and Drug Administration (FDA)—and those are just the companies whose drugs actually made it to the clinical development stage.  Getting a drug approved, in other words, can feel ...
  • CDER Ombudsman: Smaller Companies Feel Confusion, Pinch of Regulations

    A report released by the Ombudsman's Office of the US Food and Drug Administration's Center for Drug Evaluation and Research (CDER) for 2011 says smaller companies are contacting it more because they are confused about which regulations apply to them and have more to lose from an adverse decision than do larger companies. Most of the commercial companies contacting the CDER Ombudsman, which mediates disagreements between the agency and outside entities, were "smaller, em...