Legislative documents and FDA guidance documents regarding REMS

 

February 2011

Guidance for Industry
Medication Guides - Distribution and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)

Draft Guidance|Issued: February 2009

Download

 

 

September 2009

Guidance for Industry
Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications

Draft Guidance | Issued: September 30, 2009
Download

 

 

July 2009

Guidance for Industry
Postmarketing Studies and Clinical Trials — Implementation of Section 505(o) of the Federal Food, Drug, and Cosmetic Act

Draft Guidance | Issued: July 2009
Download

 

 

June 2009

Guidance for Industry
Medication Guides — Adding a Toll-Free Number for Reporting Adverse Events

Draft Guidance | Issued: June 2009
Download

 

 

March 2008

Federal Register Deemed REMS Notice
Identification of Drug and Biological Products Deemed to Have Risk Evaluation and Mitigation Strategies for Purposes of the Food and Drug Administration Amendments Act of 2007

Federal Register / Vol. 73, No. 60 | Issued: March 27, 2008
Download

 

 

September 2007

Food and Drug Administration Amendments Act of 2007

U.S. Public Law 110-85 | Signed: September 27, 2007
Download

 

 

 
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