Division of Clinical Research

Office of the Vice President and Innovation

Category results for: FDA

SAVE THE DATE: 2020 Public Training Courses, Workshops, and Meetings

January 28-30, 2020: ASM Biothreats (Arlington, VA) – Hosted by the American Society for Microbiology, to offer professionals in biodefense, biosecurity, and biological threats the opportunity to exchange knowledge and ideas, and explore the latest developments and emerging technologies. (fee) January 28-29, 2020: HHS Tick-Borne Disease Working Group public meeting (Washington, DC and webcast) – The Working Group will 1) […]

Replies to Inquiries to FDA on Good Clinical Practice

GCP inquiries submitted by the public to the FDA’s Good Clinical Practice Program’s gcp.questions@fda.hhs.gov e-mail account are now available online. FDA on GCP Link: https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/replies-inquiries-fda-good-clinical-practice Visit this FDA page to search through years of answers to GCP related questions on: Adverse Events Inquiries Computer Questions Device Study Inquiries FDA Forms 1571 and 1572 Financial Disclosure Inquiries Foreign […]

Webinar on PHUSE/FDA Data Science Innovation Challenge

October 8, 2019 10:00 a.m. – 11:00 am EDT PHUSE invites you to a special webinar announcing the “PHUSE/FDA Data Science Innovation Challenge”. The challenge provides a framework and an opportunity for the greatest minds in the data sciences arena to come together and collaborate intensively on projects during a defined time frame to create […]

Six New Modules added to CDER Learn

CDRH Learn is the FDA’s Center for Devices and Radiological Health (CDRH) web page for multimedia industry education and provides free learning modules describing many aspects of medical device and radiation-emitting product regulations, covering both premarket and postmarket topics. New modules were added on September 30, 2019: Start Here/The Basics! – (New modules 9/30/19)MDUFA Small Business […]

Recently Posted FDA Guidance Documents

9/6/2019 – Humanitarian Device Exemption (HDE) Program: Guidance for Industry and Food and Drug Administration Staff FDA developed this guidance document to provide clarity to industry and FDA staff about the current review practices for the Humanitarian Device Exemption (HDE) Program. This programmatic guidance addresses commonly asked questions about HDEs and Humanitarian Use Devices (HUDs), including FDA actions […]

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 […]

Recently Posted FDA Guidance Documents

8/7/2019 – Fabry Disease: Developing Drugs for Treatment Guidance for Industry [DRAFT] Issued by: Center for Drug Evaluation and Research The purpose of this guidance is to provide recommendations to sponsors regarding clinical trial design features that can support the approval of drugs and biological products intended for the treatment of Fabry disease (FD). 7/31/2019 […]

Sept. 11-12: FDA 2019 Science Forum

Transforming Health: Innovation in FDA Science www.fda.gov/scienceforum Dates: September 11-12, 2019 Location: Silver Spring, MD (and webcast) Forum Topic Areas include: Precision Health: Research exploring topics that may enable precision health for individuals and special populations such as sex differences, the microbiome, personalized modeling, genetics, computational modeling, and in vitro/in vivo assessment of an individual’s […]

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