FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information: Guidance for Industry

Description

This guidance document is meant to inform you, vaccine manufacturers, medical practitioners, and consumers, of the type of data that we, FDA, examine when determining the adequacy of vaccine labeling1 by providing an overview of the vaccine labeling review process and describing our review of childhood vaccine labeling under section 314 of the National Childhood Vaccine Injury Act (NCVIA).2 The processes described herein represent current FDA practices and do not represent any new interpretation of existing labeling statutes, regulations, or guidances.

Scope & Applicability

Regulatory Context

• 21CFR10.115§ 10.115 Good guidance practices.

  (a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →

• 21CFR201.57§ 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1) .

  The requirements in this section apply only to prescription drug products described in § 201.56(b)(1) and must be implemented according to the schedule specified in § 201.56(c) , except for the requirement in paragraph (c)(18) of this section to reprint any FDA-approved patient labeling at the end oRead full regulation →

• 21CFR601.2§ 601.2 Applications for biologics licenses; procedures for filing.

  (a) General. To obtain a biologics license under section 351 of the Public Health Service Act for any biological product, the manufacturer shall submit an application to the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research (see mailing aRead full regulation →

• 21CFR601.12§ 601.12 Changes to an approved application.

  (a) General.Read full regulation →

• 21CFR201.56§ 201.56 Requirements on content and format of labeling for human prescription drug and biological products.

  (a) General requirements. Prescription drug labeling described in § 201.100(d) must meet the following general requirements:Read full regulation →

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