• Regulatory NewsRegulatory News

    First-in-world 3D printed bone replacement okayed by CDRH

    The US Food and Drug Administration (FDA) has issued a first-in-world approval for a customized 3D-printed bone replacement. The Patient Specific Talus Spacer is designed to replace the talus bone, which sits at the top of the foot and forms part of the ankle joint, in patients with avascular necrosis (AVN) of the ankle.   Patients with ankle joint AVN number fewer than 8,000 yearly in the US, but the condition presents patients and their caregivers with dire options: ...
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    FDA calls for stakeholders to join MDUFA talks

    The US Food and Drug Administration (FDA) on Thursday called for non-industry stakeholders, including patient and consumer advocacy groups, to declare their interest in participating in consultation meetings for the next iteration of the Medical Device User Fee Amendments (MDUFA V) by 26 February 2021.   The monthly consultation meetings take place alongside FDA’s negotiations with regulated industry and are expected to begin next month. “FDA believes that consistent...
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    2020 Drug Safety: CDER spotlights COVID-19 activities, nitrosamine contamination

    COVID-19 was a big safety focus in 2020 for the US Food and Drug Administration (FDA), from the evaluation of drugs for emergency use authorization (EUA) to surveillance for critical drug shortages and medical product supply chain disruptions. The 2020 Drug Safety Priorities report from the FDA’s Center for Drug Evaluation and Research (CDER) chronicles a busy year in safety monitoring and enforcement, including COVID-related activities, nitrosamine impurities, and re...
  • RoundupsRoundups

    FDA Approvals Roundup: Evkeeza, Cosela, Entresto

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Evkeeza gets thumbs up as add-on therapy for inherited severely high cholesterol Regeneron’s Evkeeza (evinacumab-dgnb injection) has been approved as an add-on therapy for homozygous familial hypercholesterolemia (HoFH) in patients aged 12 years or older.   HoFH is a genetic condition that causes life-threatening, severely high levels of low...
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    OGD’s 2020 approvals, regulatory work kept pace despite COVID-19

    The US Food and Drug Administration (FDA) approved or tentatively approved 948 generic drug applications in 2020, with a significant portion aimed at potential treatments and supportive therapies for patients with COVID-19, according to the annual report from FDA’s Office of Generic Drugs (OGD).   In response to the pandemic, OGD devised a system for identifying generic drugs with the potential to treat COVID-19 and accelerating those assessments, according to OGD’s ...
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    OPDP warns AcelRx over Dsuvia promotional materials

    In its first warning letter of the year, the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) last week cited AcelRx Pharmaceuticals over promotional materials for its opioid analgesic Dsuvia (sufentanil sublingual tablet).   Specifically, the warning letter cites the company for false and misleading claims made in banner ads and a tabletop display that feature a tagline promoting the ease of administration of Dsuvia as “Tongue a...
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    CDRH officials dissect early-pandemic test guidance missteps

    A guidance permitting use of certain COVID-19 antibody tests had downstream negative consequences that the US Food and Drug Administration (FDA) did not envision when the document was issued nearly a year ago, including inappropriate use of the tests and an influx of tests based on falsified data or marketed with false claims.   In a New England Journal of Medicine editorial, two senior FDA officials laid out the agency’s experience with COVID-19 antibody tests, high...
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    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...
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    FDA warns Florida drugmaker for GMP violations

    The US Food and Drug Administration (FDA) last month warned Hialeah, FL-based drugmaker Allay Pharmaceuticals over good manufacturing practice (GMP) issues identified during a rare on-site inspection during the COVID-19 pandemic.   The warning letter cites the company for four issues observed during an inspection in May 2020 involving subpotent products and active pharmaceutical ingredient (API) testing lapses.   FDA says the company “failed to establish written pr...
  • FDA’s OPQ reports on drug quality efforts in 2020

    The office tasked with overseeing pharmaceutical quality within the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) released its annual report for 2020 on Thursday, highlighting its effort in a year marked by the COVID-19 pandemic.   In its previous annual report, the Office of Pharmaceutical Quality (OPQ) touted its participation in nearly one third of the preapproval inspections FDA carried out in 2019. For 2020, OPQ instead foc...
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    White paper addresses immuno-oncology's growing pains

    Characterizing cytokine release syndrome (CRS) will be key to ensuring broader uptake of advanced cell and gene therapies in the field of immuno-oncology, agreed authors of a newly issued white paper addressing CRS.   Speaking at a webinar hosted by the Friends of Cancer Research, Peter Marks, MD, head of the US Food and Drug Administration’s Center for Biologics Evaluation and Research (FDA’s CBER), also noted that better characterization of manufacturing process must...
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    Fresenius Kabi pays $50 million to settle criminal charges

    An Indian drug manufacturer has agreed to pay $50 million in fines and forfeitures, the US Department of Justice announced Tuesday. Fresenius Kabi Oncology Limited (FKOL) plead guilty to concealing and destroying records; the charges came in the wake of a 2013 US Food and Drug Administration (FDA) inspection of its plant in Kalyani, India.   “By hiding and deleting manufacturing records, FKOL sought to obstruct the FDA’s regulatory authority and prevent the FDA from do...