An Overview of FDA Fast Track
06/09/2020
Category: Other Blogs
FDA consultants, like Biotech Research Group, can provide support and regulatory submissions for FDA fast track service. FDA Fast Track is a...
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Time is of the Essence: Regulatory Administrative Action Letters
06/16/2019
Category: Regulatory
Human Cell, Tissue, and Cellular and Tissue-based Products (HCT/Ps) establishments are regulated under FDA’s Center of Biologics Evaluation & Research (CBER). HCT/Ps...
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What is an FDA U.S. Agent?
07/29/2018
Category: Regulatory
Establishment Registration and Product Listings Before discussion of the role of the FDA U.S. Agent, it is useful to understand Establishment Registrations...
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