Session
351 or 361? How FDA Decides What Counts as a Biologic
How FDA distinguishes Section 351(a) biologics from Section 361 HCT/Ps, and what that means for compliance planning. This is regulatory education, not legal advice.
Duration: 45 minutes.
Andrew Jonathan Hillman
Healthcare Compliance Expert Witness and Senior Paralegal
Dallas, Texas, United States
Links
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