The FDA, as part of the Prescription Drug User Fee Act (PDUFA VII), has committed to reporting aggregate and anonymized information on submissions containing real-world evidence (RWE) to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). This ongoing reporting aims to enhance understanding and confidence in the integration of #RWE in regulatory decision-making processes. This report includes: 📝 Protocols: FDA reviewed 10 RWE protocols in 2023, with 1 focused on effectiveness and 9 on safety. All 10 aimed to satisfy post-marketing requirements or commitments. 💡 Applications: FDA reviewed 4 applications in 2023 containing de novo RWE for effectiveness or safety purposes. ✅ Approvals Based on RWE: The FDA approved two drugs, Actemra (Genentech) and Vimpat (UCB), based at least in part on RWE. Read more here: https://hubs.li/Q02G5mTh0
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PG Diploma in RA, QA & short courses in Literature search, Nitrosamines, Genotoxicity, eCTD, India, LATAM submissions...IPM provides regulatory consultancy of API & Formulations for regulated & emerging markets.
USFDA published draft guidance "Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications" on September 22, 2023. The purpose of this guidance is to provide information to applicants on how FDA intends to use alternative tools to assess manufacturing facilities identified in a marketing application (i.e., a new drug application (NDA), an abbreviated new drug application (ANDA), a biologics license application (BLA), or a supplement to any of these types of applications). As part of the negotiations relating to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA), as described in “PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027” (PDUFA VII commitment letter) and “Biosimilar Biological Product Reauthorization Performance Goals and Procedures for Fiscal Years 2023 Through 2027” (BsUFA III commitment letter), FDA agreed to issue guidance on the use of alternative tools to assess manufacturing facilities named in pending applications and to incorporate best practices from the use of such tools during the Coronavirus Disease 2019 (COVID-19) pandemic. Source link: https://lnkd.in/dHu6bHrj #guidanceforindustry #usfda #guidance
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CBER revises internal procedures for processing clinical holds, NDAs and BLAs The US Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) has published two internal policy guides for staff outlining procedures for placing a clinical study on hold and addressing the administrative processing of biologics license applications (BLAs) and new drug applications (NDAs). #biologicals #usfda #biosimilars #fda #clinicaltrails #pharma #regulatoryaffairs #regulation #regulatorycomplaince #regulatory
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M. Pharm., M.B.A. (International Business), PMP®, Lean Six Sigma Certified Professional
US-FDA, Guidance for Industry: Benefit-Risk Assessment for New Drug and Biological Products The intent of this guidance is to clarify for drug sponsors and other stakeholders how considerations about a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket regulatory decisions that the Food and Drug Administration (FDA or Agency) makes about new drug applications (NDAs) as well as biologics license applications (BLAs). This guidance articulates important considerations that factor into the Center for Drug Evaluation and Research’s (CDER) and the Center for Biologics Evaluation and Research’s (CBER) benefit-risk assessments, including how patient experience data can be used to inform the benefit-risk assessment. It then discusses how sponsors can inform FDA’s benefit-risk assessment through the design and conduct of a development program, as well as how they may present benefit and risk information in the marketing application. Read more @ https://lnkd.in/dC6mrhrA
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How patient experience data can be used to inform the benefit-risk assessment.
M. Pharm., M.B.A. (International Business), PMP®, Lean Six Sigma Certified Professional
US-FDA, Guidance for Industry: Benefit-Risk Assessment for New Drug and Biological Products The intent of this guidance is to clarify for drug sponsors and other stakeholders how considerations about a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket regulatory decisions that the Food and Drug Administration (FDA or Agency) makes about new drug applications (NDAs) as well as biologics license applications (BLAs). This guidance articulates important considerations that factor into the Center for Drug Evaluation and Research’s (CDER) and the Center for Biologics Evaluation and Research’s (CBER) benefit-risk assessments, including how patient experience data can be used to inform the benefit-risk assessment. It then discusses how sponsors can inform FDA’s benefit-risk assessment through the design and conduct of a development program, as well as how they may present benefit and risk information in the marketing application. Read more @ https://lnkd.in/dC6mrhrA
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As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA VII), FDA committed to reporting aggregate and anonymized information on submissions to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) that contain real-world evidence (RWE). Applications submitted to CBER containing RWE that meet reporting criteria have been published. Data will be added annually to represent submissions by fiscal year (FY) from FYs 2023 through 2027. #fda #cber #realworlddata #realworldevidence #observationalstudies https://lnkd.in/eUV4dDgP
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The #FDA released the first annual report on submissions to the Center for Biologics Evaluation and Research (#CBER) and the Center for Drug Evaluation and Research (#CDER) with #RWE describing #submissions with analyses of #RWD to generate RWE that support regulatory decision making about a drug or biological product’s #effectiveness or #safety: https://lnkd.in/ew52ZmCw #realworldevidence #realworldoutcomes #patientjourney #realworlddata #regulatory #evidence #heor #healtheconomics #medicalaffairs #pharma #biopharma #regulatoryaffairs
Real-World Evidence Submissions to CBER and CDER
fda.gov
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FDA has published Generic Drugs 2023 Annual Report: 956- ANDAs (Approved and Tentatively Approved). 90- First Generic Drug Approvals. 119- Generic Drug Products approved with CGT designation. 158- new and revised PSGs (91 of which were for complex products) including 121 for products (69 for complex products) with no approved ANDA at the time of the PSG publication. $20 Mn- In funding provided for generic drug science and research projects. #USFDA #generic #pharmaceutical #regulatoryaffairs
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Interested in how model-integrated evidence can support generic drug development? Register to attend this webinar hosted by FDA's CDER Small Business and Industry Assistance (https://lnkd.in/ey__GE3B) on the new pilot program for meetings to discuss model-integrated evidence for generic drugs! #fda #genericdrugs https://lnkd.in/eSAwRsj2
A Deep Dive
fda.gov
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cGMP Compliance Consultant, Trainer and Auditor. CEO at NADH GXP Compliance Services,
FDA issued a draft on, "Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications" The purpose of this guidance is to provide information to applicants on how FDA intends to use alternative tools to assess manufacturing facilities identified in a marketing application (i.e., a new drug application (NDA), an abbreviated new drug application (ANDA), a biologics license application (BLA), or a supplement to any of these types of applications). FDA agreed to issue guidance on the use of alternative tools to assess manufacturing facilities named in pending applications and to incorporate best practices from the use of such tools during the Coronavirus Disease 2019 27 (COVID-19) pandemic. #cder #pharma #fda #ANDA #NDA
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Hi, Presenting the weekly API & IP Newsletter from Sidvim Lifesciences! A summary of latest and important happenings in the API & Intellectual Property space in Pharma. The key topics covered in this week edition are: Details of 505 (b) (2) filings in June 2024 Case study on Teva vs Amneal- ProAir® HFA (albuterol sulfate) 📢 We have updated our website with an enhanced Insights section. Under the Insights section you will find: API & IP Newsletters -weekly updates in the Active Pharmaceutical Ingredients & Intellectual Property space Technology newsletter and Biologics newsletters- Monthly review of advances in the Pharmaceutical Technology and Biologics space Health and Pharma News – Weekly roundup of key new items in the healthcare area Position papers- Review of recent Regulatory guidance. Price Analysis – Analysis of API, key intermediates price trends. https://www.sidvim.com/
