• Regulatory NewsRegulatory News

    FDA addresses interstate distribution of compounded drugs in new MOU

    The US Food and Drug Administration (FDA) has developed a standard memorandum of understanding (MOU) with the states that addresses interstate distribution of compounded drugs.   Under the MOU , expected to be signed by 45 states, pharmacy compounders that distribute more than 50% of their compounded drug products interstate will be identified by the states. States will be required to report certain information about these compounders to the FDA.   The 50% thresho...
  • Regulatory NewsRegulatory News

    WHO issues guidance for prequalified products amid COVID-19

    The World Health Organization (WHO) this month issued guidance detailing its expectations and flexibilities during the coronavirus (COVID-19) pandemic for manufacturers, laboratories and contract research organizations taking part in the agency's prequalifications programs. Localized adjustments in processes and procedures may be necessary for manufacturing, clinical trial and testing organizations due to the coronavirus pandemic, but should aim to minimize the risk of ...
  • Feature ArticlesFeature Articles

    Outsourcing in regulatory operations

    This case study explains Project BRIDGE and its vision to centralize process and services, such as dossier planning, compilation and publishing, submission, tracking and archiving to efficiently ensure compliance, increase transparency and maintain or improve quality of submissions to global health authorities. Introduction The author began employment at Boehringer Ingelheim, a large global pharmaceutical company with headquarters in Germany in October 2014. At that ti...
  • Regulatory NewsRegulatory News

    FDA warns against malaria drugs for COVID-19 outside hospital, clinical settings

    The US Food and Drug Administration (FDA) on Friday warned against the use of malaria drugs hydroxychloroquine and chloroquine to treat coronavirus disease (COVID-19) outside hospitals or clinical trials due to serious heart risks.   FDA says it is “aware of reports of serious heart rhythm problems,” including deaths in COVID-19 patients treated with the drugs, either alone or in combination with other QT-prolonging drugs such as azithromycin, and warns that patients w...
  • Regulatory NewsRegulatory News

    Study tracks sharp drop in FDA approvals based on 2 pivotal trials

    The proportion of drugs approved by the US Food and Drug Administration (FDA) on the strength of two or more pivotal trials fell by almost 30 percentage points over the past 20 years, according to an analysis published in JAMA Network Open.   Guidance from the late 1980s, when FDA set down its thinking on the data needed to win approval, indicate that at least two late-phase clinical trials were needed. However, FDA has long deviated from that standard in situations – ...
  • Regulatory NewsRegulatory News

    FDA reports more shortages of drugs used to put COVID-19 patients on ventilators

    Increasing demand for sedatives used to help put COVID-19 patients onto ventilators means the US Food and Drug Administration (FDA) added two more – this time the injectables propofol and dexmedetomidine – to its list of drug shortages. The propofol shortage was also previously listed by the American Society for Health-System Pharmacists (ASHP) earlier this month, with manufacturers noting increased demand. Michael Ganio, senior director of pharmacy practice and quali...
  • Regulatory NewsRegulatory News

    FDA offers guidance for generic drug developers of hydroxychloroquine, chloroquine

    The US Food and Drug Administration (FDA) on Monday issued two new product-specific guidance documents for the unproven but highly demanded potential COVID-19 drugs chloroquine phosphate and hydroxychloroquine sulfate. The two generic drugs, approved by FDA as malaria drugs, have been touted by President Donald Trump in press conferences during the pandemic, but clinical trial data regarding their efficacy for COVID-19 remain thin. Regardless, 30 million doses of hyd...
  • Regulatory NewsRegulatory News

    Compounding drugs during the pandemic: FDA offers policy clarifications

    In response to “many emails from stakeholders,” the US Food and Drug Administration (FDA) late Monday clarified a few policies related to drug compounding, including one on the limit on the interstate distribution of compounded drug products for pharmacy compounders. Overall, FDA said its policies are meant to protect patients from unsafe, ineffective and poor-quality compounded drugs while preserving access for patients. In one of the updates, FDA clarifies that a ...
  • Regulatory NewsRegulatory News

    New system to speed industry-EMA interactions on drug shortages

    The EU Executive Steering Group on Shortages of Medicines Caused by Major Events is currently establishing, with the pharmaceutical industry, the i-SPOC (industry single point of contact) system to speed up interactions on drug shortages between industry and the steering group, the European Medicines Agency (EMA) said Monday. Although medicine shortages are dealt with at the national level in the EU by national competent authorities, under this new system each pharmaceu...
  • Regulatory NewsRegulatory News

    FDA drug review times reflective of 4 key features, GAO finds

    The length of review of new drug applications (NDAs) by the US Food and Drug Administration’s (FDA) divisions is generally contingent on four features of the application, according to the Government Accountability Office’s (GAO) analysis of 637 original NDAs submitted from fiscal years 2014 through 2018. Overall, GAO found that the four key features are: 1. Whether the NDA qualifies for a priority review, which is four months less than for an otherwise standard, 10-m...
  • Regulatory NewsRegulatory News

    EMA advises on compassionate use programs for remdesivir

    The European Medicines Agency (EMA) on Friday released a set of recommendations for providing Gilead’s investigational drug remdesivir under compassionate use programs to patients with coronavirus disease (COVID-19) who are ineligible for clinical trials.   EMA says it received requests from four EU member states, Estonia, Greece, the Netherlands and Romania, asking for advice on providing early access to the drug.   Initially developed as an antiviral therapy to t...
  • Regulatory NewsRegulatory News

    PDUFA, BsUFA resource capacity planning: Report recommends refinements

    A new report from Booz Allen Hamilton commissioned by the US Food and Drug Administration (FDA) recommends refinements to the agency’s workload capacity planning adjustment methodology for its prescription drug (PDUFA VI) and biosimilar (BsUFA II) user fee programs.   Background   A workload adjustment mechanism was first introduced under PDUFA III, as “a means to adjust the annual PDUFA target revenue to account for long-term changes in the volume of certain regul...