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Category: INDs and IDEs

Webinar Materials: Final Guidances on Safety and Performance Based Pathway Criteria for Certain Device Types

On September 24, 2020, the U.S. Food and Drug Administration (FDA) hosted a webinar for industry and other stakeholders interested in learning more about two final guidance documents that provide performance criteria for the following device types in support of the Safety and Performance Based Pathway:  Conventional Foley Catheters Cutaneous Electrodes for Recording Purposes  You […]

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 […]

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

The U.S. Food and Drug Administration FDA today issued guidance for industry, investigators and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic. LINK: www.fda.gov/media/136238/download The FDA recognizes that the COVID-19 pandemic may impact the conduct of clinical trials of medical products, including drugs, devices and biological products.  Challenges may arise, for example, from quarantines, […]

Recently Posted FDA [DRAFT] Guidance Document: Inclusion of Older Adults in Cancer Clinical Trials

3/6/2020 – Inclusion of Older Adults in Cancer Clinical Trials: Draft Guidance for Industry This guidance provides recommendations regarding the inclusion of older adult patients in clinical trials of drugs for the treatment of cancer.  For the purpose of this guidance, older adults are those aged 65 years and older.  Specifically, this guidance includes recommendations for […]

FDA Public Workshop – Using Patient Preference Information in Medical Device Regulatory Decisions: Benefit-Risk and Beyond

Date: March 31, 2020 Time:8:30 AM – 4:30 PM ET Organized By: Center for Devices and Radiological Health Agenda The Food and Drug Administration (FDA), along with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), is announcing the following public workshop entitled “Using Patient Preference Information in Medical Device Regulatory Decisions:  Benefit-Risk and Beyond”. […]

Recently Posted FDA Guidance Documents

1/24/2020 – Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment: Guidance for Industry 1/22/2020 – Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff […]

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 […]

FDA Web Update: How to Determine if Your Product is a Medical Device

The Center for Devices and Radiological Health (CDRH) posted new updates on FDA.gov on December 17, 2019. The How to Determine if Your Product is a Medical Device page discusses the steps when trying to determine if a product is regulated by the FDA as a medical device and include: Step 1: Determining if your product meets the […]

FDA Guidance for Industry and FDA Staff: Qualification Process for Drug Development Tools [DRAFT]

This draft guidance provides FDA’s current thinking regarding the qualification process for drug development tools (DDTs) for a specific use, as defined in the 21st Century Cures Act. Qualification is a voluntary process that permits use of a DDT for its context of use— the defined boundaries within which the available data justifies use of […]

CDER SBIA Webinar: Forms FDA 3542a and 3542

A free On-Demand Webinar is available for viewing that addresses updates made to Forms FDA 3542a and 3542. An overview of the forms is provided as well as answers to frequently asked questions. Link: www.fda.gov/drugs/development-approval-process-drugs/demand-webinar-what-new-forms-fda-3542a-and-3542?utm_campaign=CDERSBIA%20Webinar%3A%20Form%203542&utm_medium=email&utm_source=Eloqua This webinar describes the recent updates made to Forms FDA 3542a and 3542, which NDA applicants holders use to submit […]

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