FDA Provides Information on Medication Guides Draft Guidance

April 7, 2011 9:54 am

To answer questions regarding the recently published draft “Guidance for Industry: Medication Guides – Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)” (PDF) , a questions and answers page has been added to the FDA Web site. FDA explains that the draft guidance on medication guides was developed in response to comments requesting clarification on distribution guidelines. Specifically, FDA received requests for clarification on distribution guidelines for health care providers and drug companies when drugs are given to a health care provider for administration to a patient. Several additional explanations are provided in the questions and answers on the FDA Web site. The availability of this draft guidance document and information about submitting comments was included in the March 10, 2011 NABP e-News.