Description
This guidance is intended to help applicants and reviewers in drafting the ADVERSE REACTIONS section of prescription drug labeling as required by 21 CFR 201.57(c)(7). Its primary purpose is to aid in (1) selecting information for inclusion in the section, (2) characterizing adverse reactions selected for inclusion, (3) organizing and presenting the information within the section, and (4) updating adverse reaction information. The goal of this guidance is to assist applicants in designing ADVERSE REACTIONS sections that contain the drug safety information important to patient management decisions and that convey the information in a clear and accessible format.
Scope & Applicability
Product Classes
2guidance applies to drugs regulated under section 505
Requires analytical comparability per ICH Q5E
Stakeholders
4ensure information is clear and accessible to HCPs
Entities submitting supplements to BLAs
Provide no way for prescribers to prospectively identify patients with a greater likelihood of response.
Entity submitting development data and knowledge; Entity performing the work process for change
Regulatory Context
Attributes
5Factor used to determine if an event is a reaction
Criteria for including data in tables
Comprehensive safety data collection expected to elucidate dose-response
Basis to believe a drug caused an adverse event.; The link between a drug and an adverse event
Enrollment demographics representative of disease distribution
Related CFR Sections (4)
- 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 →
- 21CFR314.126§ 314.126 Adequate and well-controlled studies.
(a) The purpose of conducting clinical investigations of a drug is to distinguish the effect of a drug from other influences, such as spontaneous change in the course of the disease, placebo effect, or biased observation. The characteristics described in paragraph (b) of this section have been develRead full regulation →
- 21CFR201.58§ 201.58 Waiver of labeling requirements.
An applicant may ask the Food and Drug Administration to waive any requirement under §§ 201.56 , 201.57 , and 201.80 . A waiver request must be submitted in writing to the Director (or the Director's designee), Center for Drug Evaluation and Research, Food and Drug Administration, Central Document RRead full regulation →
- 21CFR201.56§ 201.56 Requirements on content and format of labeling for human prescription drug and biological products.
(a) General requirements. Prescription drug labeling described in § 201.100(d) must meet the following general requirements:Read full regulation →
See Also (8)
- Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products — Content and Format (Status: Final)
- Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies: Guidance for Industry and Investigators (Status: Final)
- Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection (Status: Final)
- Best Practices in Developing Proprietary Names for Human Prescription Drug Products; Guidance for Industry: Guidance for Industry (Status: Final)
- Assessment of Pressor Effects of Drugs Guidance for Industry: Draft Guidance for Industry (Status: Draft)
- Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials: Draft Guidance for Industry; Availability (Status: Draft)
- Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (Status: Draft)
- QTc Information in Human Prescription Drug and Biological Product Labeling: Draft Guidance for Industry (Status: Draft)