Codevelopment of Two or More New Investigational Drugs for Use in Combination

Description

This guidance is intended to assist sponsors in the codevelopment2 of two or more new drugs that have not been previously developed for any indication to be used in combination to trea disease or condition. For purposes of this guidance, these not-previously-developed drugs are referred to as new investigational drugs. The guidance provides recommendations and advice on how to address certain scientific and regulatory issues that may arise during codevelopment of two or more new investigational drugs. It is not intended to apply to development of fixed combinations of previously approved drugs or to development of a single new investigational drug to be used in combination with a previously approved drug or drugs. FDA believes the recommendations in this guidance relevant to demonstrating the contribution of the individual new investigational drugs to the effect(s) of the combination are consistent with the requirements of 21 CFR § 300.50, “fixed-combination prescription drugs for humans.” This guidance applies only to drugs and biological products regulated by the Center for Drug Evaluation and Research. The guidance is not intended to apply to biological products regulated by the Center for Biologics Evaluation and Research or medical devices.

Scope & Applicability

Regulatory Context

• 21CFR314.50§ 314.50 Content and format of an NDA.

  NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead 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 →

• 21CFR300.50§ 300.50 Fixed-combination prescription drugs for humans.

  The Food and Drug Administration's policy in administering the new-drug, antibiotic, and other regulatory provisions of the Federal Food, Drug, and Cosmetic Act regarding fixed combination dosage form prescription drugs for humans is as follows:Read 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 →

• 21CFR312.33§ 312.33 Annual reports.

  A sponsor shall within 60 days of the anniversary date that the IND went into effect, submit a brief report of the progress of the investigation that includes:Read full regulation →

• In Vivo Bioavailability-Bioequivalence Studies – Clinical

  Maria A. Carballosa, M.D.

  2025-12-23

• Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)

  Celularity, Inc

  2025-12-09

• Sponsor/Investigator

  Verdure Sciences, Inc.

  2025-11-18

• Clinical Investigator (Sponsor)

  Pamela K. Den Besten, DDS, MS

  2025-09-30

• 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

• Clinical Investigator (Sponsor)

  American Behavioral Research Institute, LLC

  2025-06-10

• Bioresearch Monitoring Program

  Amy Lightner, MD

  2025-06-03

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