| Health / Medical Topics |
Correspondence
Routine: administrative changes, e.g., change of address, authorized official, or meeting requests. Donor re-entry request: An applicant's request to re-enter a deferred donor when regulations and/or guidance do not provide a qualification method or process for their specific situation. (21 CFR 610.41(b)) License re-issuance: request from applicant to change legal name. Lot distribution report: Postmarketing report required by 21 CFR 600.81 to be submitted every six (6) months upon approval/licensing of vaccine or biologic product. Final printed labeling. (Food and Drug Administration)
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