FDA Issues Draft Guidance on Patient Counseling Info for Labeling - - BioPharm International

ADVERTISEMENT

FDA Issues Draft Guidance on Patient Counseling Info for Labeling


FDA has released its draft guidance, Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products—Content and Format. The document gives guidance on the development of patient counseling information on labels has required under § 201.57(c)(18) (21 CFR 201.57(c)(18)). The guidance is intended to assist applicants with deciding what topics to include in a label’s patient counseling information section as well as the presentation and organization of those topics.

A final rule amending requirements for the content and formatting of labeling, published on Jan. 24, 2006, created the new required section, Patient Counseling Information (§ 201.57(c)(18)). The section summarizes the information that a healthcare provider should convey to a patient. According to the draft guidance, patient-counseling information must contain information necessary for patients to use the drug safely and effectively and, if applicable, reference to FDA-approved patient labeling.

Source: FDA.gov

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

First Biosimilar Application Kicks Off Legal Battle
October 31, 2014
FDA Approves Pfizer's Trumenba for the Prevention of Meningitis B
October 30, 2014
EMA: Extrapolation Across Indications for Biosimilars a Possibility
October 30, 2014
Bristol-Myers Squibb Announces Agreement to Acquire HER2-Targeted Cancer Treatment
October 29, 2014
Amgen, Sanofi, and Ono Pharmaceuticals Partner with Universities on Transmembrane Protein Research
October 28, 2014
Author Guidelines

Click here