Description
This guidance provides information to sponsors about FDA’s implementation of Title VIII of the Food and Drug Administration Safety and Innovation Act (FDASIA), titled Generating Antibiotic Incentives Now (GAIN). The GAIN provisions create incentives for the development of antibacterial and antifungal drug products that treat serious or life-threatening infections. The purpose of this guidance is to provide sponsors a resource for information on FDA’s policies and procedures related to the designation of a qualified infectious disease product (QIDP) under GAIN.
Scope & Applicability
Product Classes
4Drugs 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
Defined as an antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections.
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Stakeholders
2Entity responsible for submitting applications under section 524B
entity submitting marketing applications
Regulatory Context
Attributes
2Required information for RLD/RS and proposed products.; Product characteristic in ANDA background
Exclusivity period granted under section 505E(a)
Related CFR Sections (3)
- 21CFR317.2§ 317.2 List of qualifying pathogens that have the potential to pose a serious threat to public health.
The term “qualifying pathogen” in section 505E(f) of the Federal Food, Drug, and Cosmetic Act is defined to mean any of the following:Read full regulation →
- 21CFR314.3§ 314.3 Definitions.
(a) The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act apply to those terms when used in this part and part 320 of this chapter .Read full regulation →
- 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
See Also (8)
- Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry (Status: Draft)
- Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting: Guidance for Industry (Status: Final)
- Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route (Status: Final)
- Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn Guidance for Industry (Status: Draft)
- Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products (Status: Draft)
- Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples: Draft Guidance for Industry (Status: Draft)
- Controlled Correspondence Related to Generic Drug Development (Status: Final)
- Migraine: Developing Drugs for Preventive Treatment (Status: Draft)