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BLOGS
Binh Nguyen
Dec 14, 20243 min read
Combination Products and Landscape
Did you know that Office of Combination Products (OCP) at FDA was established in 2002 as required by Sec. 204 of the Medical Device User...
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Binh Nguyen
Dec 14, 20243 min read
Release by Exception - Should it be done?
What is release by exception? In manufacturing, there are instances where things may not always go as planned. It can be minor or major...
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Binh Nguyen
Dec 5, 20241 min read
Human Gene Therapy - Hopeful Regulatory Pathway for Patients to Access Precision or Personalized Medicines
Some diseases are so rare that going through the traditional Phases 1, 2, and 3 studies would be too costly and time consuming and quite...
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