Description
This guidance provides FDA’s current thinking regarding the requirements for submission of field alert reports (FARs) by applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and outlines FDA’s recommendations for FAR submissions to help improve their consistency and relevancy. The guidance also addresses certain frequently asked questions.
Scope & Applicability
Product Classes
4Products 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.
Positron emission tomography drugs
Gases subject to FAR requirements
The scope of FAR requirements applies only to products that have been distributed.
Stakeholders
4entity submitting marketing applications
Entity seeking to use the alternative reporting process.; entity responsible for seeking alternative reporting processes
Representative of a foreign owner who serves as the FSVP importer; Person in the US acting as a communications link or FSVP representative.; Designated representative for foreign owners; designated representative for foreign owners
The firm usually listed as the site where the problem occurred.
Regulatory Context
Attributes
1The mandatory timeframe for submitting a FAR after receiving reportable information.
Identified Hazards
Hazards
2Trigger for FAR submission; A condition in a distributed drug that requires a FAR.
determines if VQIP food is subject to for cause examination
Related CFR Sections (7)
- 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 →
- 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 →
- 21CFR314.98§ 314.98 Postmarketing reports.
(a) Each applicant having an approved abbreviated new drug application under § 314.94 that is effective must comply with the requirements of § 314.80 regarding the reporting and recordkeeping of adverse drug experiences.Read full regulation →
- 21CFR211.192§ 211.192 Production record review.
All drug product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Any unexplained discrepancy (inRead full regulation →
- 21CFR211.198§ 211.198 Complaint files.
(a) Written procedures describing the handling of all written and oral complaints regarding a drug product shall be established and followed. Such procedures shall include provisions for review by the quality control unit, of any complaint involving the possible failure of a drug product to meet anyRead full regulation →
- 21CFR212.71§ 212.71 What actions must I take if a batch of PET drug product does not conform to specifications?
(a) Rejection of nonconforming product. You must reject a batch of a PET drug product that does not conform to specifications. You must have and follow procedures to identify and segregate the product to avoid mix-ups. You must have and follow procedures to investigate the cause(s) of the nonconformRead full regulation →
- 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 →
Related Warning Letters (10)
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
SV Labs Corporation
- 2025-12-11
CGMP/Finished Pharmaceuticals/Adulterated
Catalent Indiana, LLC
- 2025-12-02
Compounding Pharmacy/Adulterated Drug Products
PQ Pharmacy, LLC
- 2025-12-02
Compounding Pharmacy/Adulterated Drug Products
Turbare Manufacturing
- 2025-12-02
CGMP/Finished Pharmaceuticals/Adulterated
Rhyz Analytical Labs
- 2025-11-25
Compounding Pharmacy/Adulterated Drug Products
Wells Pharma of Houston, LLC
- 2025-11-18
Nonprescription/OTC
DermaRite Industries, LLC
- 2025-11-04
CGMP/Finished Pharmaceuticals/Adulterated
Liebel-Flarsheim Company LLC
- 2025-11-04
CGMP/Finished Pharmaceuticals/Adulterated
Apotex Inc.
- 2025-10-07
CGMP/Finished Pharmaceuticals/Adulterated
Naturich Cosmetique Labs
See Also (8)
- Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products (Status: Final)
- Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act (Status: Draft)
- Control of Nitrosamine Impurities in Human Drugs: Guidance for Industry (Status: Final)
- 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)