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Experienced researchers and technicians are at your service when you partner with American Preclinical Services. You gain one-stop access to full biocompatibility, interventional, and surgical research and pathology services within a world-class facility. ISO 17025 accredited, AAALAC accredited, USDA licensed, and GLP compliant, American Preclinical Services offers you the bundled resources you require to achieve rigorous medical device testing in a single laboratory operation.

Share on Google+ September 18, 2017

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FDA’s plan to engage the public in the agency’s new effort to strengthen and modernize FDA’s regulatory framework

Category : FDA

On 07 September, 2017, FDA announced its plan to engage the public in the agency’s new effort to strengthen and modernize FDA’s regulatory framework. FDA’s goal is to ensure that its policies and regulations keep pace with the challenges encountered in protecting consumers, and the opportunities to improve lives. This new effort includes areas where FDA’s rules concerning new drugs

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Share on Google+ September 11, 2017

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Strengthening EU-US cooperation in medicine inspections

Category : FDA

New commitment allows FDA to share full inspection reports with European Commission and EMA The European Commission (EC), the United States (US) Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have signed a new confidentiality commitment that allows the US regulator to share non-public and commercially confidential information, including trade secret information relating to medicine inspections with

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Share on Google+ September 4, 2017

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FDA Announces the Medical Device User Fee Rates for Fiscal Year 2018

Category : FDA, Medical Device testing

On 29 August 2017, the Food and Drug Administration (FDA) announced the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2018.  The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), authorizes FDA to collect user fees are for certain medical

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Share on Google+ August 28, 2017

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American Preclinical Services Receives AAALAC’s Global 3Rs Award for North America.

Category : Coronary Artery Disease, Uncategorized

American Preclinical Services (APS) has been awarded AAALAC’s Global 3Rs Award for all of North America (there are two-three other winners for other continents). This AAALAC award recognizes our development of a new testing methodology, the In-vitro Blood Loop Assay, as a replacement for the Canine NonAnticoagulated Venous Implant (NAVI) Model for testing thrombogenicity of medical devices. This is truly a

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Share on Google+ August 7, 2017

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Pathology Matters, part 3 of a 3 part series: Semiquantitative Histopathology Scoring

Category : Uncategorized

Preclinical studies generating semiquantitative histopathology data are welcomed by regulatory agencies because, theoretically, reproducible and comparable results would be obtained with independent observers. But is that necessarily the case? Many factors influence the interpretation and reproducibility of semiquantitative data. Histopathology results are dependent on establishing appropriate scoring criteria. Semiquantitative scoring, with categorical ranking of observed changes, is also subject to

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Share on Google+ July 10, 2017

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Pathology Matters, part 2 of a 3 part series: Assessing Histopathology Results

Category : Histopathology, Interventional Medicine, Medical Device testing

Part 1 of this series described the preclinical study types relying heavily on histopathology data: device safety, biocompatibility, and systemic toxicity. Here we focus on strategies for histopathology data assessment. Preclinical study histopathology data can generally be divided into three types: Qualitative Quantitative Semiquantitative Qualitative histopathology uses description to document tissue changes and is more applicable to studies where the

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