APS’ incoming CSO brings years of experience in pharmaceutical and medical device research
As Dr. Jim Pomonis of APS gets ready to step into the next stage of his career, he can lookRead more.
World-class facilities empower preclinical success
To achieve truly revolutionary breakthroughs in the field of medical science, you need the right tools. At American Preclinical Services,Read more.
FDA Finalizes 510(k) Guidances on When to Submit a New 510(k)
On October 25, 2017, the FDA released two final guidance documents: Deciding When to Submit a 510(k) for a ChangeRead more.
FDA’s plan to engage the public in the agency’s new effort to strengthen and modernize FDA’s regulatory framework
On 07 September, 2017, FDA announced its plan to engage the public in the agencys new effort to strengthen andRead more.
Strengthening EU-US cooperation in medicine inspections
New commitment allows FDA to share full inspection reports with European Commission and EMA The European Commission (EC), the UnitedRead more.
FDA Announces the Medical Device User Fee Rates for Fiscal Year 2018
On 29 August 2017, the Food and Drug Administration (FDA) announced the fee rates and payment procedures for medical deviceRead more.
American Preclinical Services Receives AAALAC’s Global 3Rs Award for North America.
American Preclinical Services (APS) has been awarded AAALACs Global 3Rs Award for all of North America (there are two-three otherRead more.
Pathology Matters, part 3 of a 3 part series: Semiquantitative Histopathology Scoring
Preclinical studies generating semiquantitative histopathology data are welcomed by regulatory agencies because, theoretically, reproducible and comparable results would be obtainedRead more.
Pathology Matters, part 2 of a 3 part series: Assessing Histopathology Results
Part 1 of this series described the preclinical study types relying heavily on histopathology data: device safety, biocompatibility, and systemicRead more.