Description
This guidance is intended to assist applicants in drafting the INDICATIONS AND USAGE section of labeling as described in the regulations for the content and format of labeling for human prescription drug and biological products2 (21 CFR 201.57(c)(2)).
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
4guidance applies to drugs regulated under section 505
Labeling must include strategies for reducing drug-resistant bacteria.
Regulated under section 351(i) of the PHS Act; Virus, therapeutic serum, toxin, vaccine, or protein applicable to prevention or treatment; Alternative regulation category for products meeting device definition
Requires analytical comparability per ICH Q5E
Stakeholders
2Entity submitting development data and knowledge; Entity performing the work process for change
users of the labeling instructions for preparation and administration
Regulatory Context
Regulatory Activities
2Pathway for drugs and biologics for serious conditions; Regulatory pathway supported by surrogate or intermediate endpoints; Regulatory pathway based on surrogate or intermediate endpoints; Pathway for products based on surrogate or intermediate clinical endpoints
Required under the Pediatric Research Equity Act for new indications.
Document Types
2Cybersecurity information should be included in device labeling
Content and format guidance for human prescription drug and biological products.
Attributes
4convey the use(s) for which the drug has been shown to be safe and effective
The brand name or trade name of a drug product
Description of a drug's use in patients with a history of events.
Used for patient stratification or predictive enrichment strategies.
Technical Details
Substances
3Example of a drug class used in therapy history.
immunogenicity evaluation of the reference product
Example of a pharmacologic class.
Testing Methods
2Specific test used to detect anaplastic lymphoma kinase.
Used to select patients for specific drug therapies.
Processes
3Example of a concomitant therapeutic modality.
Chronic intrathecal infusion of DRUG-X via a device.
Example of a primary mode of therapy.
Clinical Concepts
10Target of CDS recommendations for prevention, diagnosis, or treatment
relationship between diastolic blood pressure and the rates of stroke and coronary heart disease
Example for incidence estimate involving flare-ups
DRUG-X is indicated for the treatment of severe spasticity.
manifestation or symptoms thereof
Target population for efficacy extrapolation
Defined as patients 65 years of age and older; Patients 65 years of age and older; Patient population for which drug use knowledge must be evaluated.
Number of events for Nonfatal Myocardial Infarction in trials
Prognostic baseline covariate
Required condition for the drug development population; Management of diabetes mellitus patient populations
Identified Hazards
Hazards
1Safety concerns that may require warnings for withdrawn indications
Related CFR Sections (7)
- 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 →
- 21CFR201.24§ 201.24 Labeling for systemic antibacterial drug products.
The labeling of all systemic drug products intended for human use indicated to treat a bacterial infection, except a mycobacterial infection, must bear the following statements:Read 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 →
- 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 →
- 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 →
- 21CFR312.41§ 312.41 Comment and advice on an IND.
(a) FDA may at any time during the course of the investigation communicate with the sponsor orally or in writing about deficiencies in the IND or about FDA's need for more data or information.Read full regulation →
See Also (8)
- Clinical Development and Labeling of Anti-Infective Drug Products (Status: Final)
- Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Content and Format (Status: Final)
- Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway (Status: Final)
- Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn Guidance for Industry (Status: Draft)
- Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines: Guidance for Industry (Status: Final)
- Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines: Guidance for Industry (Status: Final)
- Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (Status: Final)
- Clinical Considerations for Therapeutic Cancer Vaccines: Guidance for Industry (Status: Final)