Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines: Guidance for Industry

Description

This document is intended to provide to you, sponsors of seasonal inactivated influenza vaccines, guidance on clinical development approaches to support a Biologics License Application (BLA). The approaches in this guidance apply to both nonadjuvanted and adjuvanted hemagglutinin-based seasonal vaccines, including "split virus," subunit, and whole virus inactivated vaccines propagated in embryonated chicken eggs or cell-culture, and to recombinant hemagglutinin-based protein vaccines, and DNA vaccines that express hemagglutinin. This document does not address live attenuated influenza vaccines or influenza vaccines that do not rely on immunity to a hemagglutinin component.

Scope & Applicability

Regulatory Context

• 21CFR600.3§ 600.3 Definitions.

  As used in this subchapter:Read full regulation →

• 21CFR314.126§ 314.126 Adequate and well-controlled studies.

  (a) The purpose of conducting clinical investigations of a drug is to distinguish the effect of a drug from other influences, such as spontaneous change in the course of the disease, placebo effect, or biased observation. The characteristics described in paragraph (b) of this section have been develRead full regulation →

• 21CFR312.23§ 312.23 IND content and format.

  (a) A sponsor who intends to conduct a clinical investigation subject to this part shall submit an “Investigational New Drug Application” (IND) including, in the following order:Read full regulation →

• 21CFR312.32§ 312.32 IND safety reporting.

  (a) Definitions. The following definitions of terms apply to this section:Read full regulation →

• 21CFR312.56§ 312.56 Review of ongoing investigations.

  (a) The sponsor shall monitor the progress of all clinical investigations being conducted under its IND.Read full regulation →

• 21CFR312.60§ 312.60 General responsibilities of investigators.

  An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs Read full regulation →

• 21CFR312.62§ 312.62 Investigator recordkeeping and record retention.

  (a) Disposition of drug. An investigator is required to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects. If the investigation is terminated, suspended, discontinued, or completed, the investigator shall return the unused supplies of the drug tRead full regulation →

• 21CFR601.41§ 601.41 Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.

  FDA may grant marketing approval for a biological product on the basis of adequate and well-controlled clinical trials establishing that the biological product has an effect on a surrogate endpoint that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, tRead full regulation →

• 21CFR601.43§ 601.43 Withdrawal procedures.

  (a) For biological products approved under § 601.41 or § 601.42 , FDA may withdraw approval, following a hearing as provided in part 15 of this chapter , as modified by this section, if:Read 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 →

• Clinical Investigator/Sponsor

  Ralph A. DeFronzo, M.D.

  2025-09-23

• Clinical Investigator

  Shirish M. Gadgeel, M.D.

  2025-09-09

• Clinical Investigator

  Mark J. Savant, M.D

  2025-07-15

• Clinical Investigator

  Peter Michael, M.D.

  2025-07-01

• Bioresearch Monitoring Program

  Amy Lightner, MD

  2025-06-03

• Clinical Investigator

  Nana Barseghian, M.D.

  2025-05-06

• Clinical Investigator

  Mehran Michael Bahrami, M.D.

  2025-03-18

• Clinical Investigator

  Han C. Phan, M.D.

  2024-12-03

• Clinical Investigator

  Namita A. Goyal, M.D.

  2024-10-22

• Clinical Investigator

  Julio R. Flamini, M.D./Clinical Integrative Research Center of Atlanta

  2024-09-03

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