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September 10, 2021

FDA-M CERSI: Analgesic Clinical Trial Designs, Extrapolation, and Endpoints in Patients from Birth to Less Than Two Years of Age Public Workshop – 10/13/2021 – 10/14/2021

On This Page Date: October 13 – 14, 2021 Day1: Wed, Oct 13 10:00 AM – 2:00 PM ET Day2: Thu, Oct 14 10:00 AM – […]
September 9, 2021

Public Workshop on COVID-19 Lessons Learned: Clinical Evaluation of Therapeutics – 09/28/2021 – 09/28/2021

Workshop Scheduled Content current as of: 09/09/2021 Regulated Product(s)
September 9, 2021

Transcript: Definition of a Drug (April 2017)

Host: Captain Catherine ChewPharmacist: Lieutenant Commander Lindsay Wagner CAPT Chew: Is it a drug, a cosmetic, or both?  This is a question consumers may ask their […]
September 8, 2021

FDA’s Role in Foreign Drug Manufacturing (November 2017)

[embedded content] FDA Drug Info Rounds pharmacists discuss how FDA works with both domestic and foreign drug manufacturers to help ensure that products distributed within the […]
September 8, 2021

Expanded Access Part 1: Introduction (May 2019)

[embedded content] What is Expanded Access? FDA Chief Project Manager Monica Hughes discusses a potential pathway for a seriously ill patient to gain access to an […]
September 8, 2021

Expanded Access Part 4: How to Complete Form FDA 3926 for Follow-up Submissions (September 2019)

[embedded content] FDA Chief Project Manager Monica Hughes provides step-by-step instructions on completing Form FDA 3926 for follow-up submissions. Content current as of: 09/16/2019 Regulated Product(s)
September 8, 2021

Expanded Access Part 2: How to Submit a Single Patient IND (September 2019)

[embedded content] FDA Chief Project Manager Monica Hughes provides an overview on the submission process for emergency and non-emergency expanded applications from the initial request to […]
September 8, 2021

Transcript: Expanded Access Part 3: How to Complete Form FDA 3926 for Initial Submissions

Form FDA 3926 is a one-page form, front and back. Detailed instructions are available on the FDA website. Form FDA 3926 covers both initial and follow-up […]
September 8, 2021

Transcript: Expanded Access Part 4: How to Complete Form FDA 3926 for Follow-up Submissions (September 2019)

Now that you are the sponsor of a Single Patient IND, do you understand the expectations and requirements for treating a patient under expanded access? After […]
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