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  • Regulatory NewsRegulatory News

    FDA offers draft guidance for registries as RWD

    The US Food and Drug Administration (FDA) released draft guidance on the use of registries in regulatory decision making, adding another piece to the puzzle of how the agency will consider real-world data (RWD) when considering a new drug indication or assessing post-approval requirements.   The draft guidance , which was published Monday, outlines considerations for sponsors and stakeholders when proposing to design a registry or use an existing registry to support r...
  • ReconRecon

    Recon: Blueprint's $250M preclinical buy; WHO, CDC, Biden react to Omicron variant

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden says omicron variant is cause for concern but not panic ( NPR ) CDC Statement on B.1.1.529 (Omicron variant) ( CDC ) Pfizer boosts Paxlovid manufacturing capacity as Merck’s rival COVID pill hits surprise efficacy setback ( Fierce ) Opinion: Becerra needs to open up to the press ( AHCJ ) Opinion: Will Moderna Ever Learn to Share? ( MedPage Today ) Who ...
  • RoundupsRoundups

    FDA Approvals Roundup: Voxzogo, Fyarro, Livtencity

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).    New approvals   Voxzogo cleared  as growth-improvement therapy for children with dwarfism   BioMarin’s  Voxzogo (vosoritide injection) has been  approved  for improv ing growth in children aged 5 years or older with achondroplasia and open epiphyses, or growth plates.    Achondroplasia is the most common form of dwarfism. Children with open  epiph...
  • Regulatory NewsRegulatory News

    Smiths Medical warned by FDA for multiple violations

    The US Food and Drug Administration (FDA) slapped Smiths Medical in Minneapolis, MN with a warning letter for inadequate procedures for handling medical device reports (MDRs), faulty handling of complaints, inadequate validation processes, and lax corrective and preventative actions (CAPA) procedures. The company makes blood warmers and infusion pumps.   The warning letter was issued on 1 October and posted on 23 November. It follows a recent recall of the company’s ...
  • Regulatory NewsRegulatory News

    FDA suggests alternative approaches for nitrosamine risk assessments

    The US Food and Drug Administration (FDA) has suggested that manufacturers consider using certain antioxidants or excipients, such as sodium carbonate, to their drug products to inhibit the formation of nitrosamine impurities.   These approaches were outlined in recent update on possible mitigation strategies to reduce the risk of nitrosamine impurities in drug products. The update was prompted by reports of certain types of nitrosamine impurities that formed in “sever...
  • Regulatory NewsRegulatory News

    FDA shares research to improve dose selection in pediatric drug development

    Dose selection is a significant challenge in pediatric drug development; commonly used renal function equations can overestimate glomerular filtration rates and result in inaccurate predictions of drug elimination.   In a Regulatory Science in Action article , scientists from the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) shared findings about how adjustments to the estimated glomerular filtration rate (eGFR) equations could help ...
  • Feature ArticlesFeature Articles

    Recent FDA approvals of drugs and biologics for children

    This article provides a summary of drugs and biologic products that have recently become available for the pediatric population in the United States. It highlights prescription products for attention deficit hyperactivity disorder (ADHD), psoriasis, active polyarticular juvenile idiopathic arthritis (pJIA), active psoriatic arthritis, Ebola virus treatment, spinal muscular atrophy, and bladder dysfunction that became available in 2019, 2020, and 2021 after completion of pe...
  • Regulatory NewsRegulatory News

    This Week at FDA: mRNA boosters for most; Blood lancets reclassified

    Welcome to our weekly digest of regulatory news from the US Food and Drug Administration (FDA), legislative updates, and other news updates we think you’ll find useful — and interesting. This week saw COVID-19 vaccine and therapy updates, the unveiling of Cures 2.0 , and lots of device updates. As usual, we welcome feedback at news@raps.org .    Friday morning, the US Food and Drug Administration (FDA) announced an expansion of the emergency use authorizations (EUA...
  • Regulatory NewsRegulatory News

    GDUFA III fiscal details emerge

    The generics industry can expect the US Food and Drug Administration (FDA) to take a more flexible approach to resource capacity planning and continue a commitment to financial transparency, according to fiscal experts from the agency who spoke at an FDA meeting earlier this week.   Although much of the framework for the third reauthorization of the Generic Drug User Fee Amendments (GDUFA III) program could be gleaned from the commitment letter released by the US Foo...
  • Regulatory NewsRegulatory News

    Industry, clinician groups have different wish lists for AI/ML-enabled device labels

    Medical device industry groups are urging the U.S. Food and Drug Administration (FDA) not to rush to create new regulatory requirements around the labeling of medical devices that incorporate artificial intelligence or machine learning (AI/ML), while clinician groups are seeking greater transparency about device algorithms and training data sets.     In total, 15 groups offered comments following a virtual public workshop held by FDA on the transparency of AI/ML-enable...
  • Regulatory NewsRegulatory News

    FDA urged to endorse EPCIS to spur manufacturers' uptake of DSCSA

    The pharmaceutical industry and other trading partners told the US Food and Drug Administration (FDA) to endorse the use of Electronic Product Code Information Services (EPCIS) for tracing products through the supply chain by finalizing its guidance on standards for the interoperable exchange of product information.   Doing so would help improve industry’s uptake of exchanging product data well ahead of the November 2023 deadline when these systems go live, say trading...
  • RoundupsRoundups

    FDA Approvals Roundup: Besremi

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approval Besremi okayed for rare blood disease PharmaEssentia’s Besremi (ropeginterferon alfa-2b-njft injection) has been approved for treating adults with polycythemia vera, a blood disease caused by a JAK2V617F mutation that results in overproduction of red blood cells (RBCs).   The monopegylated, long-acting interferon alfa-2b reduces excess RBCs...