Documents in the NTIS Technical Reports collection are the results of federally funded research. They are directly submitted to or collected by NTIS from Federal agencies for permanent accessibility to industry, academia and the public.  Before purchasing from NTIS, you may want to check for free access from (1) the issuing organization's website; (2) the U.S. Government Printing Office's Federal Digital System website; (3) the federal government Internet portal; or (4) a web search conducted using a commercial search engine such as
Accession Number PB2014-100662
Title Guidance for Industry: Safety Labeling Changes: Implementation of Section 505(o)(4) of the FD&C Act.
Publication Date Jul 2013
Media Count 21p
Personal Author N/A
Abstract This guidance provides information on the implementation of section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(o)(4)), which was added by section 901 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). Section 505(o)(4) authorizes FDA to require certain drug and biological product application holders to make safety-related labeling changes based on new safety information that becomes available after approval of the drug or biological product.
Keywords Biological products
Federal Food Drug and Cosmetic Act(FD&C Act)
Industry guidance
Public health

Source Agency Center for Devices and Radiological Health
NTIS Subject Category 57Q - Pharmacology & Pharmacological Chemistry
96D - Consumer Affairs
Corporate Author Food and Drug Administration, Rockville, MD. Center for Biologics Evaluation and Research.
Document Type Technical report
Title Note N/A
NTIS Issue Number 1401
Contract Number N/A

Science and Technology Highlights

See a sampling of the latest scientific, technical and engineering information from NTIS in the NTIS Technical Reports Newsletter

Acrobat Reader Mobile    Acrobat Reader