Regulatory Filing & Pre- License/Pre-Approval Inspections of ...
Regulatory Filing & Pre- License/Pre-Approval Inspections of ...
Regulatory Filing & Pre- License/Pre-Approval Inspections of ...
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
Current Laws‣ Public Health Service Act – Section 351(a)(2)(B)• Licensure <strong>of</strong> biological establishments and products– Biological product is safe, pure, and potent– Facility meets standards to assure a safe, pure, andpotent product– Applicant (or other appropriate person) consents to theinspection <strong>of</strong> the facility‣ Federal Food, Drug and Cosmetic Act• Interprets that “biological products” are also “drugs”• Applies to a biological product except no applicationrequired under Section 505<strong>Inspections</strong> under the provisions <strong>of</strong> both Acts (PHS & FD&C)4
Change language