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Tag: FDA submissions

FDA webinar: CDER’s NextGen Portal

Still submitting paper to CDER? Send electronically with CDER’s NextGen Portal instead! (for submissions not required in eCTD) This webinar provides an overview of CDER’s NextGen Portal for those in industry who are currently not required to submit in eCTD and are sending information to CDER in paper. CDER’s NextGen Portal is designed to allow a sponsor […]

Recently Posted FDA Guidance Documents

12/20/2019 – Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff The Food and Drug Administration (FDA) has developed this document to describe relevant information that should be included in test report summaries, test protocols and complete test reports for non-clinical bench performance testing provided […]

Recently Posted FDA Guidance Documents

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on August 29, 2019. To view listings for other dates, see CDRH New – News and Updates. Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions This guidance document describes the Food and […]

Regulatory Education for Industry (REdI): Clinical Investigator Training Course

November 12-14, 2019 The Hotel at the University of Maryland, College Park, MD The course fee is $500 and includes attendance to program sessions, coursebook with all speaker slides, breakfast on November 12-14, and daily refreshment breaks. A room block is available for the rate of $179/night This course provides a study of clinical trial […]

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