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Accession Number PB2013-101005
Title Guidance for Industry and Investigators Safety Reporting Requirements for INDs and BA/BE Studies .
Publication Date Dec 2012
Media Count 32p
Personal Author N/A
Abstract This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. This guidance is intended to help sponsors and investigators comply with the requirements for investigational new drug (IND) safety reporting and safety reporting for bioavailability (BA) and bioequivalence (BE) studies under 21 CFR 312.32, 312.64(b), and 320.31(d)(3). This document provides guidance to sponsors and investigators on expedited safety reporting requirements for human drug and biological products that are being investigated under an IND and for drugs that are the subjects of BA and BE studies that are exempt from the IND requirements. This guidance defines terms used for safety reporting, makes recommendations on when and how to submit a safety report, and provides advice on other safety reporting issues that have arisen from sponsors and investigators.
Keywords Bioavailability
Bioequivalence
Biological products
Biopharmaceutics classification system
Compliance
Drug applications
Drug safety
Industry guidance
Investigative new drugs(INDs)
Recommendations
Requirements


 
Source Agency Office of Management and Operations
NTIS Subject Category 57Q - Pharmacology & Pharmacological Chemistry
57Y - Toxicology
Corporate Author Food and Drug Administration, Bethesda, MD. Center for Biologics Evaluation and Research.
Document Type Technical report
Title Note N/A
NTIS Issue Number 1310
Contract Number N/A

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