Expedited Programs for Serious Conditions | Drugs and Biologics

Description

The following four FDA programs are intended to facilitate and expedite development and review of new drugs to address unmet medical need in the treatment of a serious or lifethreatening condition: fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation (see section IV for an overview of the programs). The purpose of this guidance for industry is to provide a single resource for information on FDA’s policies and procedures for these four programs as well as threshold criteria generally applicable to concluding that a drug is a candidate for these expedited development and review programs.

Scope & Applicability

Regulatory Context

• 21CFR314.101§ 314.101 Filing an NDA and receiving an ANDA.

  (a) Filing an NDA.Read full regulation →

• 21CFR202.1§ 202.1 Prescription-drug advertisements.

  Prescription drug as used in this section means any drug defined in section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act or § 201.105 of this chapter , applicable to drugs intended for use by humans and to veterinary drugs, respectively.Read full regulation →

• 21CFR314.150§ 314.150 Withdrawal of approval of an application or abbreviated application.

  (a) The Food and Drug Administration will notify the applicant, and, if appropriate, all other persons who manufacture or distribute identical, related, or similar drug products as defined in §§ 310.6 and 314.151(a) of this chapter and for a new drug afford an opportunity for a hearing on a proposalRead 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 →

• 21CFR314.530§ 314.530 Withdrawal procedures.

  (a) For new drugs approved under §§ 314.510 and 314.520 , FDA may withdraw approval, following a hearing as provided in part 15 of this chapter , as modified by this section, if:Read full regulation →

• 21CFR601.45§ 601.45 Promotional materials.

  For biological products being considered for approval under this subpart, unless otherwise informed by the agency, applicants must submit to the agency for consideration during the preapproval review period copies of all promotional materials, including promotional labeling as well as advertisementsRead full regulation →

• 21CFR314.550§ 314.550 Promotional materials.

  For drug products being considered for approval under this subpart, unless otherwise informed by the agency, applicants must submit to the agency for consideration during the preapproval review period copies of all promotional materials, including promotional labeling as well as advertisements, inteRead 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 →

• 21CFR314.510§ 314.510 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 new drug product on the basis of adequate and well-controlled clinical trials establishing that the drug product has an effect on a surrogate endpoint that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predicRead full regulation →

• 21CFR312.300§ 312.300 General.

  (a) Scope. This subpart contains the requirements for the use of investigational new drugs and approved drugs where availability is limited by a risk evaluation and mitigation strategy (REMS) when the primary purpose is to diagnose, monitor, or treat a patient's disease or condition. The aim of thisRead full regulation →

• 21CFR312.81§ 312.81 Scope.

  This section applies to new drug and biological products that are being studied for their safety and effectiveness in treating life-threatening or severely-debilitating diseases.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

• Advertising & Promotional Labeling/Drugs/Biological Products

  CSL Behring

  2025-09-16

• False & Misleading Claims/Misbranded

  Aytu Biopharma

  2025-09-16

• False & Misleading Claims/Misbranded

  Novo Nordisk Inc.

  2025-09-16

• False & Misleading Claims/Misbranded

  Eli Lilly and Company

  2025-09-16

• False & Misleading Claims/Misbranded

  Alora Pharmaceuticals

  2025-09-16

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