Description
This guidance provides information on the implementation of section 506(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by section 3042 of the 21st Century Cures Act, which established the limited population pathway for antibacterial and antifungal drugs (LPAD pathway).
Scope & Applicability
Product Classes
5drugs intended to treat serious bacterial infections in patients with unmet medical need; New antibacterial drugs that treat serious bacterial diseases in patients with an unmet medical need
Drugs approved under the LPAD pathway
Drugs intended for the LPAD pathway
Drugs used to treat B. burgdorferi or B. mayonii infections
Drug products intended to treat serious or life-threatening infections; Drug type eligible for QIDP designation
Stakeholders
2Entity responsible for submitting applications under section 524B
Entity submitting development data and knowledge; Entity performing the work process for change
Regulatory Context
Attributes
2Assessment for approval in a limited population
Required labeling statement for LPAD drugs
Related CFR Sections (7)
- 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 →
- 21CFR601.12§ 601.12 Changes to an approved application.
(a) General.Read full regulation →
- 21CFR314.81§ 314.81 Other postmarketing reports.
(a) Applicability. Each applicant shall make the reports for each of its approved applications and abbreviated applications required under this section and section 505(k) of the act.Read 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 →
- 21CFR600.3§ 600.3 Definitions.
As used in this subchapter:Read full regulation →
- 21CFR312.80§ 312.80 Purpose.
The purpose of this section is to establish procedures designed to expedite the development, evaluation, and marketing of new therapies intended to treat persons with life-threatening and severely-debilitating illnesses, especially where no satisfactory alternative therapy exists. As stated § 314.10Read full regulation →
Related Warning Letters (10)
- 2025-09-16
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
- 2025-06-10
False & Misleading Claims/Misbranded
Sprout Pharmaceuticals, Inc.
- 2025-05-20
False & Misleading Claims/Misbranded
Sarfez Pharmaceuticals, Inc.
- 2025-03-11
False & Misleading Claims/Misbranded
Aurora Pharmaceutical
- 2025-03-11
False & Misleading Claims/Misbranded
Elanco Animal Health
- 2024-03-12
False & Misleading Claims/Misbranded
Boehringer Ingelheim Animal Health USA
See Also (8)
- Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements (Status: Final)
- Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs (Status: Final)
- Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers : Guidance for Industry (Status: Final)
- Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling-Final (Status: Final)
- Contents of a Complete Submission for the Evaluation of Proprietary Names (Status: Final)
- Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs (Status: Draft)
- Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (Status: Draft)
- Expedited Programs for Serious Conditions | Drugs and Biologics (Status: Final)