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WHERE MEDICAL INNOVATIONS TAKE FLIGHT

preclinical

FDA Issues Notice of Proposed Rulemaking Regarding 21 CFR Part 58, Good Laboratory Practice (GLP).

The proposed changes would affect all participants in GLP trials:  Sponsors, Testing Facilities and supporting laboratory services.  We encourage all affected parties to review and comment on the proposed changes.  The public comment period for the proposed changes closes November 22, 2016.  Details on the proposed changes and how to comment are available on the […]

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New Guidance! FDA New Guidance for Industry, General Considerations for Animal Studies for Medical Devices

On October 14, 2015, FDA released a draft guidance entitled, “General Considerations for Animal Studies for Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff“.  The purpose of this document is, once final, to supercede FDA’s current Guidance entitled General Considerations for Animal Studies for Cardiovascular Devices, which was issued on July […]

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preclinical

APS’ Continued Commitment to quality

APS Receives FDA Clean Bill of Health APS is committed to quality. In March 2014, APS was inspected by the FDA for compliance to 21 CFR Part 58, FDA Good Laboratory Practice. During this multi-day inspection, the FDA thoroughly reviewed APS’ quality systems. The outcome of this audit demonstrated that APS was in full compliance […]

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