Does the TransCelerate RbM Guidance Offer Standardization?
Beat Widler & Peter Schiemann quoted on Applied Clinical Trials Blog Post
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New FDA Draft Guidance on Expanded Access:
Individual Patient Expanded Access Applications: Form FDA 3926
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Applied Clinical Trials
RbM Guidance Document published on “Applied Clinical Trials”
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RbM Guidance Document: Ten Burning Questions about Risk-Based Study Management
You can read this document and others in our Resources/Publications section. Read the pdf Visit the publications section
And finally another FDA Final Guidance for Industry
Providing Regulatory Submissions in Electronic Format-Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act
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