draft guidance

FDA Releases Draft Guidance on Inclusion of Males in Breast Cancer Trials

9/03/2019

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Male breast cancer is rare, but nonetheless as deadly as for women when at the same stage of progression. Men have been traditionally excluded from breast cancer clinical trials, so any treatment for them has been developed with data from women subjects. This results in fewer FDA approved treatment options for men with breast cancer.

Live Webinar Identifying Workforce Gaps in RBM: August 13

7/30/2019

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Topic: Identifying Workforce Gaps Post Risk-Based Monitoring (RBM): It’s Time to “DIG” in!

Date: August 13, 2019

Time: 1:00 p.m. – 2:00 p.m. EDT

Duration: 60 minutes

Sponsored by: Life Science Training Institute

Webinar: Live interactive session. Recording will be available for 30 days.

Sign up here.

Comment Now! Enhancing the Diversity of Clinical Trial Populations (Draft Guidance)

6/25/2019

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The Food and Drug Administration (FDA) released a draft guidance “Enhancing the Diversity of Clinical Trial Populations - Eligibility Criteria, Enrollment Practices, and Trial Designs”. It is the position of the FDA to enroll subjects who are the target audience for the investigational product once approved. Certain populations are underrepresented in clinical trials, even though they are part of the target audience. The draft guidance outlines methods the sponsor can use to support more diverse enrollment that more accurately reflects the target population, in accordance with requirements in the FDA Reauthorization Act of 2017 (FDARA).

Comment Now! Rare Disease: Natural History Studies for Drug Development (FDA Draft Guidance)

4/11/2019

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The Food and Drug Administration (FDA) has released a draft guidance, “Rare Diseases: Natural History Studies for Drug Development”. We discussed another draft guidance released in January, “Rare Diseases: Common Issues in Drug Development” in our blog. The new draft guidance describes how natural history studies may be best used for drug development for rare diseases.

New Draft Q&A Guidance on RBM Released: Comment Now!

3/21/2019

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The Food and Drug Administration released a new draft guidance, “A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers Guidance for Industry”. The purpose of the guidance is to provide additional clarification to the finalized Risk Based Monitoring (RBM) guidance from 2013. Questions and answers provide details about: