Description
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled “Useful Written Consumer Medication Information (CMI).” CMI is written information developed for consumers about prescription drugs that is distributed to consumers when they have prescriptions filled. The guidance discusses general issues and makes recommendations on the content of useful written CMI.
Scope & Applicability
Product Classes
4products subject to DSCSA tracing requirements
New strength of Tradename for Oral Suspension 6 mg/mL.
Early-phase randomized, double-blind, parallel assignment clinical study
Cefaclor is in a class of medicines known as cephalosporin antibiotics.
Stakeholders
8Entities that dispense the drug and must maintain certification; Pharmacies that dispense are specially certified under ETASU B
Participant involved in the medication use process and REMS
Medical professionals involved in prescribing or administering the drug
organizations developing CMI
organizations developing CMI
Part of the shared oversight infrastructure in a master protocol.
FDA advisory committee that reviewed name testing approaches.
Administers the drug to the patient
Regulatory Context
Attributes
3A criterion for determining the usefulness of CMI.
Required label element for outsourcing facilities
The recommended readability level for CMI wording.
Related CFR Sections (4)
- 21CFR310.501§ 310.501 Patient package inserts for oral contraceptives.
(a) Requirement for a patient package insert. The safe and effective use of oral contraceptive drug products requires that patients be fully informed of the benefits and the risks involved in their use. An oral contraceptive drug product that does not comply with the requirements of this section is Read full regulation →
- 21CFR310.515§ 310.515 Patient package inserts for estrogens.
(a) Requirement for a patient package insert. FDA concludes that the safe and effective use of drug products containing estrogens requires that patients be fully informed of the benefits and risks involved in the use of these drugs. Accordingly, except as provided in paragraph (e) of this section, eRead 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 →
- 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 →
See Also (8)
- Labeling for Combined Hormonal Contraceptives Guidance for Industry (Status: Draft)
- Classification Categories for Certain Supplements Under BsUFA III (Status: Final)
- Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies: Guidance for Industry (Status: Final)
- Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics Marketing Applications: Guidance for Industry (Status: Final)
- FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information: Guidance for Industry (Status: Final)
- Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format: Guidance for Industry (Status: Final)
- Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims: Guidance for Industry (Status: Final)
- Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims (Status: Final)