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Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act | FDA

Docket Number: FDA-2023-D-2204 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act.” This guidance provides recommendations for industry and review staff on the formal dispute resolution (FDR) and administrative hearings procedures for resolving scientific and/or medical disputes between the Center for Drug Evaluation and Research (CDER) and requestors and sponsors of drugs that will be subject to a final administrative order under section 505G of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (“Final Order”). This guidance finalizes the draft guidance of the same title issued on June 23, 2023. Submit Comments Submit Comments Online You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)) If unable to submit comments online, please mail written comments to: Dockets Management Food and Drug Administration 5630 Fishers Lane, Rm 1061 Rockville, MD 20852 All written comments should be identified with this document's docket number: FDA-2023-D-2204.

Biosimilars Research: Awards

The bioassay initiative: enhanced biosimilar testing capabilitiesOPQ/OPQRMay 20232-3 yearsResearch Priority C: Define best-practices for assessing and reporting quality attributesEnhancing CDER bioassay capabilities to additional attributes to provide definition, standardization, and harmonization of expectations for assessing and reporting CQAs, while reducing inconsistencies and unnecessary testingImpact 1: Increase reliance on analytical data in a demonstration of biosimilarity 2025 Annual Report 2024 Annual Report Establishment of a Feasible Method to Quantify Glycoforms of Human IgG1 mAb Drugs and their Biosimilars in Culture Media as a Component of Process Analytic Technology OPQ/OPQRMay 20232 yearsResearch Priority B: Explore how modernization of analytical technologies could better and/or more efficiently detect relevant quality attributesDevelop mouse monoclonal antibodies against human non-glycosylated and glycosylated IgG1, and establish a Biolayer Interferometry (BLI) method to quantify the major glycoforms of human IgG1 mAb drugsImpact 1: Increase reliance on analytical data in a demonstration of biosimilarity 2025 Annual Report 2024 Annual Report Develop acceptance parameters and standards for the Innate Immune Response Modulating Impurities (IIRMI) assays in the Biosimilar spaceOPQ/OPQRApril 20233 yearsResearch Priority D: Develop alternatives to comparative clinical immunogenicity assessment(s)Develop in vitro assays that can be used to reduce/replace clinical trials to assess immunogenicity risk of biosimilarsImpact 2: Develop alternatives to and/or reduce the size of studies involving human subjects 2025 Annual Report 2024 Annual Report One-Pot Glycan - a chemoenzymatic method for simultaneous profiling and comparison of N- and O-glycansOPQ/OPQRApril 20232-3 yearsResearch Priority B: Explore how modernization of analytical technologies could better and/or more efficiently detect relevant quality attributes​Establish and validate a chemoenzymatic method for simultaneous profiling and comparison N-and O-glycans from purified proteins and protein drugs in a One-Pot formatImpact 1: Increase reliance on analytical data in a demonstration of biosimilarity 2025 Annual Report 2024 Annual Report Model development and verification to evaluate minimum stability data required for biosimilar submissionsOPQ/OPQRSeptember 20233 yearsResearch Priority B: Characterize relationships between product quality attributes with clinical outcomesDetermine the minimum amount of stability data required to accurately predict long term stability and support biosimilar product’s shelf-lifeImpact 1: Increase reliance on analytical data in a demonstration of biosimilarity 2025 Annual Report 2024 Annual Report Landscape Assessment of Biosimilar SubmissionsOTS/OCP/DARSMay 20231 yearResearch Priority A: Characterize relationships between product quality attributes with clinical outcomesConduct a landscape analysis to determine how FDA can answer questions about whether differences in analytical assessments in biosimilar development programs do or do not corelate with clinical dataImpact 1: Increase reliance on analytical data in a demonstration of biosimilarity2024 Annual ReportAddressing fundamental issues for in vitro immunogenicity testingOTS/OCP/DARSMay 20231 yearResearch Priority D: Develop alternatives to comparative clinical immunogenicity assessment(s)Validate methods for in vitro immunogenicity testing that could be used by industry to reduce/eliminate the need for clinical trials assessing immunogenicity for biosimilar drug productsImpact 2: Develop alternatives to and/or reduce the size of studies involving human subjects 2025 Annual Report 2024 Annual Report Validation of a non-clinical immunogenicity modelOTS/OCP/DARSApril 20231 yearResearch Priority D: Develop alternatives to comparative clinical immunogenicity assessment(s)Evaluate the ability of humanized mice to serve as a non-clinical immunogenicity model by evaluating several biological drug products (with clinically moderate to high immunogenicity) alone or in combination in the two most commonly used humanized mouse modelsImpact 2: Develop alternatives to and/or reduce the size of studies involving human subjects 2025 Annual Report 2024 Annual Report Production & optimization of humanized miceOTS/OCP/DARSSeptember 20231 yearResearch Priority D: Develop alternatives to comparative clinical immunogenicity assessment(s)Use an established protocol for producing immune humanized mice to generate a cohort for answering regulatory questions related to pharmacokinetics, pharmacodynamics, immunogenicity and adverse events that have not been successfully addressed with other nonclinical modelsImpact 2: Develop alternatives to and/or reduce the size of studies involving human subjects 2025 Annual Report 2024 Annual Report Critical Factors for Standardization and Accuracy of PK Assays of PEGylated Biosimilars OTS/OCP/DARSSeptember 20231 year Research Priority E: Define development approaches that will increase feasibility and/ or likelihood of successProvide guidance/best practices to industry for evaluating pharmacokinetics (PK) associated with biosimilars that are conjugated to polyethylene glycol (PEG)Impact 2: Develop alternatives to and/or reduce the size of studies involving human subjects​ 2025 Annual Report 2024 Annual Report Translating Clinical Pharmacology Biosimilar Research Findings into Best Practices for Industry and FDA Review StaffOTS/OCP/DARSSeptember 20231 yearResearch Priority E: Define development approaches that will increase feasibility and/ or likelihood of successCloseout of bioanalytical and omics related project activities from the ‘Pharmacodynamic Biomarkers for Biosimilar Approval’ projectImpact 2: Develop alternatives to and/or reduce the size of studies involving human subjects2024 Annual ReportEvidence-based approach to the design of clinical pharmacology studiesOTS/OCPSeptember 20232 yearsResearch Priority E: Define development approaches that will increase feasibility and/ or likelihood of successIncrease the efficiency of biosimilar development programs by leveraging clinical pharmacology studiesImpact 2: Develop alternatives to and/or reduce the size of studies involving human subjects​ 2025 Annual Report 2024 Annual Report Assessment of Immunogenicity in Biosimilars a Systematic ReviewOND/OTBBOctober 20252 yearsResearch Priority A: Characterize relationships between product quality attributes with clinical outcomesTo examine immunogenicity data reviewed by the FDA as included in submissions for approved biosimilars and the corresponding pharmacokinetics (PK) and safety data in a definitive manner using a PRISMA based Systematic Review to determine if associations exist antidrug antibody status and clinical safety events such as hypersensitivityImpact 1: Increase reliance on analytical data in a demonstration of biosimilarityThe annual report for this project will be shared once available.Assessment of the performance of MAM vs conventional QC methods for evaluation of Product Quality Attributes of adalimumab and etanerceptU.S. PHARMACOPEIAAugust 20222-3 yearsResearch Priority B: Explore how modernization of analytical technologies could better and/or more efficiently detect relevant quality attributesTo assess the performance of the MS-based MAM versus conventional QC methods to identify changes in PQAs upon forced degradation and to correlate changes in those PQAs with bioactivity, binding affinity, and structure.Impact 1: Increase reliance on analytical data in a demonstration of biosimilarity​ 2023 Annual Report 2024 Annual Report Platform for reliable characterization and evaluation of comparability of biosimilar drug products in lyophilized and liquid formulations​NATIONAL INSTITUTE FOR PHARM TECH/EDUCAugust 20222-3 yearsResearch Priority C: Define best-practices for assessing and reporting quality attributesTo develop a platform for reliable characterization and evaluation of comparability of biosimilar drug products in lyophilized and liquid formulationsImpact 1: Increase reliance on analytical data in a demonstration of biosimilarity 2023 Annual Report 2024 Annual Report Systematic Analytical Characterization of Innovator and Biosimilar Products with the Focus on Post-translational Modifications​UNIVERSITY OF MICHIGAN AT ANN ARBORAugust 20222-3 yearsResearch Priority C: Define best-practices for assessing and reporting quality attributesTo develop novel methodologies to evaluate structural similarities and differences between innovator and multiple biosimilar products and apply them across different protein drug classes. The proposed work will establish the correlation between post-translation modification differences, receptor binding, antibody dependent cellular cytotoxicity, aggregation propensity, immunogenicity and clinical efficacy to aid approvals of biosimilar and interchangeable protein products.Impact 1: Increase reliance on analytical data in a demonstration of biosimilarity 2023 Annual Report 2024 Annual Report ISPRI-HCP: CHO protein impurity immunogenicity risk prediction for improving biosimilar product development and assessing product interchangeability​EPIVAX, INC.August 20222-3 yearsResearch Priority D: Develop alternatives to comparative clinical immunogenicity assessment(s)To improve the ISPRI-HCP immunogenicity risk prediction model for biosimilar product development and assessing product interchangeabilityImpact 2: Develop alternatives to and/or reduce the size of studies involving human subjects 2023 Annual Report 2024 Annual Report Bridging the Gap: Using Foreign Real-World Data to Inform Interchangeable Biosimilar Approvals​ACADEMY OF MANAGED CARE PHARMACY, INC.September 20232-3 yearsResearch Priority D: Develop alternatives to comparative clinical immunogenicity assessment(s)To support research projects that enhance biosimilar and interchangeable biological product development and regulatory science.Impact 2: Develop alternatives to and/or reduce the size of studies involving human subjects 2025 Annual Report 2024 Annual Report

Wind-sculpted landscapes: Investigating the Martian megaripple 'Hazyview'

While much of Perseverance's work focuses on ancient rocks that record Mars' long-lost rivers and lakes, megaripples offer a rare opportunity to examine processes that are still shaping the surface today. Megaripples are sand ripples up to 2 meters (about 6.5 feet) tall that are mainly built and modified by wind. However, when water in the atmosphere interacts with dust on the ripple surface, a salty, dusty crust can form. When this happens, it is much harder for the wind to move or shape the megaripple.

Five new planets and the battle for their atmospheres

One of the primary goals of the James Webb Space Telescope (JWST) is to detect atmospheres around exoplanets, to try to suss out whether or not they could potentially support life. But, in order to do that, scientists have to know where to look, and the exoplanet has to actually have an atmosphere.

AI uncovers double-strangeness: A new double-Lambda hypernucleus

Researchers from the High Energy Nuclear Physics Laboratory at the RIKEN Pioneering Research Institute (PRI) in Japan and their international collaborators have made a discovery that bridges artificial intelligence and nuclear physics. By applying deep learning techniques to a vast amount of unexamined nuclear emulsion data from the J-PARC E07 experiment, the team identified, for the first time in 25 years, a new double-Lambda hypernucleus.

Decades-long quest leads to first scholarly accurate fossil replica of 'dinosaur-killer' croc

Dr. David Schwimmer, an expert on the giant North American crocodilian genus Deinosuchus and a Columbus State University geology professor, has contributed his research to the creation of the first-ever scholarly accurate, mounted skeleton replica of the species Deinosuchus schwimmeri. Known for decades as a "dinosaur-killer," Deinosuchus was almost certainly the apex predator of its day.

Deepest gas hydrate cold seep ever discovered in the Arctic at 3,640 m depth

A multinational scientific team led by UiT has uncovered the deepest known gas hydrate cold seep on the planet. The discovery was made during the Ocean Census Arctic Deep–EXTREME24 expedition and reveals a previously unknown ecosystem thriving at 3,640 meters on the Molloy Ridge in the Greenland Sea. The groundbreaking findings regarding the Freya Hydrate Mounds, which hold scientific significance and implications for Arctic governance and sustainable development, have recently been published in Nature Communications.

Warming may make tropical cyclone 'seeds' riskier for Africa

An existing body of research indicates that climate change is making tropical cyclones wetter and more powerful. Now, a new study is indicating the same thing may be happening to the precursors of these storms: the wet weather systems that sometimes give rise to destructive hurricanes and often cause hazardous rain and flooding. The findings are published in the Journal of Advances in Modeling Earth Systems.

Disaster after disaster: Do we have enough raw materials to 'build back better?'

This Christmas Day marks 21 years since the terrifying Indian Ocean tsunami. As we remember the hundreds of thousands of lives lost in this tragic event, it is also a moment to reflect on what followed. How do communities rebuild after major events such as the tsunami, and other disasters like it? What were the financial and hidden costs of reconstruction?

How climate campaigns can cut through ad fatigue

Since November 2025, commuters at Southwark tube station in London have been passing walls lined with vintage-style posters parodying oil and gas advertising, instead of ads promoting flights or energy companies. One 1950s-style poster shows a woman holding a small yellow airplane as if it were a cigarette; another has the slogan: For a quicker climate crisis use … Fossil Ads.

Cells reveal 'survival of the fittest' through ribosome competition

Ribosomes—the tiny factories that build proteins in our cells—don't all work with the same efficiency. Researchers from Japan have discovered that ribosomes actually compete with one another, and those that perform poorly are selectively broken down when more efficient ones are present. This built-in "survival of the fittest" mechanism keeps protein synthesis accurate and efficient, shedding new light on how cells maintain quality control and prevent ribosome-related diseases.

Q&A: The science of snowflakes—how hexagonal symmetry and environmental changes create endless designs

In the iconic "Sound of Music" score, "My Favorite Things," a young Julie Andrews lists snowflakes as objects that bring her joy. While some people would rather avoid snowflakes and the slippery roads that accompany them, no one can deny the beauty and intricacy captured within these ephemeral shards of ice.

The dual impact of stellar bars on star formation in galaxy pairs

Professor Woong-bae Zee of the College of Liberal Studies at Sejong University has revealed that a galaxy does not possess only a single evolutionary pathway; instead, depending on the nature of its neighboring galaxy, it can exhibit two entirely different "faces of evolution." The work is published in The Astrophysical Journal.

Hubble glimpses galactic gas making getaway

A sideways spiral galaxy shines in this NASA/ESA Hubble Space Telescope image. Located about 60 million light-years away in the constellation Virgo (the Maiden), NGC 4388 is a resident of the Virgo galaxy cluster. This enormous cluster of galaxies contains more than a thousand members and is the nearest large galaxy cluster to the Milky Way.