• 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, ...
  • RoundupsRoundups

    FDA Approvals Roundup: Scemblix, Vuity, Cortrophin Gel

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Scemblix okayed for chronic myeloid leukemia with Philadelphia mutation Novartis’s Scemblix (asciminib) has been granted accelerated approval as a therapy for adults with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML in CP) who have received previous treatment with two or more tyrosine kinase inhibitors (...
  • ReconRecon

    Recon: Democrats cobble together drug pricing deal; WHO grants emergency use listing to Bharat Biotech's COVID vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Democrats Add Drug Cost Curbs to Social Policy Plan, Pushing for Vote ( NYTimes ) ( STAT ) Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial ( The BMJ ) U.S. begins vaccinating its youngest against COVID-19 ( Reuters ) CDC advisers endorse Pfizer’s Covid-19 vaccine for kids 5-11 ( STAT ) With two new insurance partnersh...
  • Regulatory NewsRegulatory News

    GDUFA III commitment letter details coming changes to FDA's generic review program

    With the negotiations for the third iteration of the Generic Drug User Fee Amendments (GDUFA III) program completed, the US Food and Drug Administration (FDA) has released the commitment letter laying out its performance goals and the program enhancements that will shape the program over the next five years.   The commitment letter follows a year-long process of meetings and negotiation sessions to gather input from the public, industry and other stakeholders on the ag...
  • Regulatory NewsRegulatory News

    Wound dressing firm warned for design, environmental control issues

    An Ohio firm that is both an own-label distributor and specification developer of sterile wound dressings received a warning letter from the US Food and Drug Administration (FDA) for ongoing problems including a lack of medical device reporting procedures, design control issues, and lack of document and environmental control, among others.   CellEra LLC, which distributes wound dressings with drugs such as silver, petrolatum and collagen, received the 20 October warnin...
  • RoundupsRoundups

    Asia-Pacific Roundup: India seeks feedback on creating regulatory framework that supports innovation

    India has proposed regulatory reforms intended to encourage R&D and innovation in the pharma and medtech industries. The proposals are part of a broader plan to make India a leader in drug discovery and innovative medical devices by establishing an entrepreneurial environment in the country.   In working toward the goal, the Department of Pharmaceuticals (DoP) is proposing to simplify India’s regulatory processes to enable rapid drug discovery and innovation in medical...
  • ReconRecon

    Recon: Opioid makers score a win in California trial; Pfizer sees 2021, 2022 COVID vaccine sales to hit $65B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Opioid Makers Win Major Victory in California Trial ( NYTimes ) ( Reuters ) ( STAT ) Pfizer expects 2021, 2022 COVID-19 vaccine sales to total at least $65 bln ( Reuters ) ( FT ) U.S. CDC advisers to vote on COVID-19 vaccine in young children ( Reuters ) FDA extends review of J&J, Legend's cell therapy for multiple myeloma ( BioPharmaDive ) Progressive Democr...
  • Regulatory NewsRegulatory News

    FDA official: Growing number of enforcement actions stem from inspection alternatives

    Many of the US Food and Drug Administration’s (FDA) drug good manufacturing practice (GMP) warning letters and import alerts issued in fiscal year 2021 were based on product sampling and reviewing firms’ written responses to record requests, not from traditional onsite inspections.   So asserted Francis Godwin, director of Office of Manufacturing Quality (OMQ) in FDA’s Center for Drug Evaluation and Research (CDER) at a compliance and enforcement update at a 26 October...
  • Regulatory NewsRegulatory News

    FDA issued vaccine EUAs without facility inspections: GAO

    Manufacturers of COVID-19 vaccines currently authorized for emergency use did not undergo facility inspections before their vaccines were authorized by the US Food and Drug Administration (FDA), said the General Accounting Office (GAO) in a new report. However, most facilities had been inspected at least once previously in past 10 years, and the agency relied on a variety of other information sources including record reviews and on-site reviews.   The examination of th...
  • Regulatory NewsRegulatory News

    Nitrosamine detection tests should be 'fit for purpose,' says FDA

    Pharmaceutical manufacturers should ensure that the analytical tests they are using are “fit for purpose” to ensure that the right test is measuring the right impurity in testing their drugs for nitrosamines, says Jason Rodriguez, director of the division of complex drug analysis at the US Food and Drug Administration’s (FDA’s) Office of Testing and Research in St. Louis. Manufacturers should also use orthogonal, or additional methods, to double-check results.   Rodrig...
  • ReconRecon

    Recon: Novavax gets first emergency authorization in Indonesia; J&J pays $800M to settle most Risperdal suits

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna says FDA needs more time to complete review of its COVID-19 shot for adolescents ( Reuters ) ( NYTimes ) Orphan drug tax credit on the chopping block again under Dem spending bill ( Endpoints ) Pelosi working to gather support for last-minute, last-ditch drug pricing policy ( STAT ) In key win, AbbVie lands FDA approval for Allergan's blurred-vision ey...
  • Feature ArticlesFeature Articles

    Data integrity remediation and cGMP facilities

    Data integrity remediation is a critical activity performed by analytical laboratories, quality control laboratories, and manufacturing plants to comply with good manufacturing practice (GMP) and data integrity requirements. There are various challenges during this activity, and current GMP (cGMP) facilities struggle to comply due to technical limitations and resource constraints. This article examines the data integrity remediation challenges faced by cGMP facilities and ...