Description
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Safety Labeling Changes—Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act." This draft guidance provides information on the implementation of the statutory provision that authorizes FDA to require application holders for certain drug and biological products to make labeling changes based on new safety information that becomes available after approval of the drug that FDA determines should be included in the labeling of the drug. This guidance is being updated and reissued in draft to, among other things, include the addition of information related to Congress’ 2018 changes to the definition of adverse drug experience regarding reduced effectiveness and make other changes to reflect current Agency processes and procedures regarding safety labeling changes. This draft guidance revises and, when finalized, will replace the guidance for industry entitled "Safety Labeling Changes—Implementation of Section 505(o)(4) of the FD&C Act" issued in July 2013.
Scope & Applicability
Product Classes
3Products with approved NDAs or ANDAs subject to SLC provisions.
development program for drug and biological products
The drug referenced by an ANDA.
Stakeholders
3The entity responsible for responding to SLC notifications and orders.; Entity responsible for submitting labeling supplements or rebuttals; Entity responsible for submitting labeling supplements and appeals
Internal FDA board providing input on labeling extensions
External body providing input on labeling changes
Regulatory Context
Attributes
1Can form the basis for regulatory action if it meets the definition of a serious adverse drug experience
Identified Hazards
Hazards
3Associated with the use of a drug that FDA becomes aware of post-approval
A risk not previously identified or expected based on the drug's profile
Information triggering the need for safety labeling changes
Related CFR Sections (3)
- 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
- 21CFR601.12§ 601.12 Changes to an approved application.
(a) General.Read full regulation →
- 21CFR10.75§ 10.75 Internal agency review of decisions.
(a) A decision of an FDA employee, other than the Commissioner, on a matter, is subject to review by the employee's supervisor under the following circumstances:Read full regulation →
See Also (8)
- Postapproval Changes to Drug Substances Guidance for Industry (Status: Draft)
- SUPAC-IR Questions and Answers about SUPAC-IR Guidance (Status: Final)
- Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry (Status: Draft)
- Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products: Guidance for Industry (Status: Final)
- Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products (Status: Final)
- Environmental Assessment of Human Drug and Biologics Applications: Guidance for Industry (Status: Final)
- Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability (Status: Final)
- For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h: Guidance for Industry (Status: Final)